Hypertriglyceridemia-associated acute pancreatitis: Response to continuous insulin infusion

Vishnu Priya Pulipati; Ambika Amblee; Sara Elizabeth T. Yap; Hafeez Shaka; Bettina Tahsin; Leon Fogelfeld

doi:10.1371/journal.pone.0260495

Peer Review History

Original SubmissionAugust 4, 2021
14 Sep 2021 Decision Letter - Zoltán Rakonczay Jr., Editor PONE-D-21-25261Hypertriglyceridemia-Associated Acute Pancreatitis: Response to Continuous Insulin InfusionPLOS ONE Dear Dr. Amblee, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Your paper has been reviewed by three experts in the field. Notably they have mentioned that the methods section should be expanded by providing further details (e.g. concerning i.v. hydration or continuous insulin infusion). Please also check your manuscript for typos. Please submit your revised manuscript by Oct 29 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. 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Upon resubmission, please provide the following: ● The name of the colleague or the details of the professional service that edited your manuscript ● A copy of your manuscript showing your changes by either highlighting them or using track changes (uploaded as a supporting information file) ● A clean copy of the edited manuscript (uploaded as the new manuscript file) [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: Yes Reviewer #3: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The aim of this retrospective case series is to analyze the outcome of to continuous insulin infusion in hypertriglyceridemia-associated acute pancreatitis. It was concluded that continuous insulin infusion was effective in reducing serum triglyceride level in the majority of patients. Presence of diabetes, higher BMI and initial triglyceride slowed the time needed to effectively reduce serum triglyceride level. There are many case reports and series demonstrating the effectiveness of insulin in lowering triglyceride level. This study provides data about the quantity of insulin and the duration required to reduce effectively the serum triglyceride level. Criticisms: 1. Fasting and intravenous hydration applied in the treatment of acute pancreatitis rapidly and greatly reduces serum triglyceride level and can be as effective as intravenous insulin. Provide data about the applied intravenous fluid therapy in the first days of your patients. Intravenous hydration can be a confounding factor in this study. Please, discuss it. 2. Was dextrose infusion applied as part of the parenteral fluid therapy in the study? Please, provide details in the Methods. 3. Could you give data about the severity and outcome of acute pancreatitis especially in the RP and NR, SRP and RRP group, respectively? 4. What is the 75th percentile in this data from table 2? 4 [0.5] 5. Page 12: ‘Figure 1: Consort Table’. Some contradiction: is it a figure or table? ‘Patient’s flow chart’ is suggested to be used. 6. Page 22: ‘Figure 1’ is supposed to be Figure 2. What is the meaning of gosl? Please use the word time/Time, insulin/Insulin consistently. 7. The style of references does not follow the requirements of the journal. 8. There are many typos in the manuscript. Some of them: Abstract: kg/m2…instead of …kg/m 2… Abstract: …HbA1c… instead of …HbA1C… Page 10: …abdominal pain… instead of…. pain abdomen… Repeatedly:…. p = 0.130… instead of …p 0.130… Table 2 title: …. less than 36 hours vs 36 hours …instead of … less than vs 36 hours … Table 2:… 36 hours or more… instead of … 36 hours or More … Table 2: … (hours) … instead of … hours)… Reviewer #2: 1. Please review abstract. Currently not able to be interpreted easily. 2. "CII is an effective modality of therapy to reduce acutely the TG levels" - please review syntax 3. "AP was defined per Atlanta classification of acute pancreatitis 2012 as any two of the three following criteria: pain abdomen (acute onset, persistent, severe, epigastric pain often radiating to the back), pancreatic enzymes (serum lipase or amylase) level at least 3 times greater than the upper limit of normal, computed tomography (CT) or magnetic resonance imaging (MRI) evidence of acute pancreatitis" - please correct to abdominal pain 4. Why were pregnant women excluded from this study? 5. "Secondary outcomes were time durations to achieve TG-50% (half of the respective initial TG) and time durations to achieve TG-goal" - please take out durations 6. What is your institution's protocol about rate and concentration of dextrose delivery? This will affect insulin doses 7. "The four patients who did not reach TG-goal (NR, non-responders) had a long time to initiation of CII (3 [0, 5.5] vs 10 [2.2, 37.2] hr, p 0.130) but otherwise did not differ from RP" - p value suggests this is not significant Reviewer #3: In this manuscript authors investigated efficacy of continuous insulin insfusion on lowering triglyceride levels in patients with hypertriglyceridemic pancreatitis. They also search for the factors that can predict treatment success. This study gives a new insight how insulin, as a triglyceride lowering agent, could be used in patients with hypertriglyceridemic pancreatitis and which parameters could help in titration of therapy. In the current literature this kind of data are lacking so this manuscript is of great importance from the clinical and research points of view. Introduction provides good and concise background of the topic. The objective is clearly defined. Methodology of the study is well designed but continuous insulin infusion protocol could be explained in a more detailed way (quantity of insulin in infusion, type and volume of solution, frequency of glucose checks, goal glucose levels and adjustment of infusion rate). Other components of methodology, inclusion/exclusion criteria and outcomes are thoroughly written. Results are well presented. Tables and figures are clear, informative and easy to follow. The data provide enough evidence to make a conclusions. Discussion gives good perspective of current knowledge and how findings of this study can upgrade clinical practice. Conclusions are well presented and supported by the data. The literature cited is relevant to the study. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No Reviewer #3: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. 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Revision 1
22 Oct 2021 Author Response Journal Requirements: 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Data included as Supplemental Materials 2. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified (1) whether consent was informed and (2) what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information. If you are reporting a retrospective study of medical records or archived samples, please ensure that you have discussed whether all data were fully anonymized before you accessed them and/or whether the IRB or ethics committee waived the requirement for informed consent. If patients provided informed written consent to have data from their medical records used in research, please include this information. Information about de-identified data added to Methods section, page 4. 3. We suggest you thoroughly copyedit your manuscript for language usage, spelling, and grammar. If you do not know anyone who can help you do this, you may wish to consider employing a professional scientific editing service. Whilst you may use any professional scientific editing service of your choice, PLOS has partnered with both American Journal Experts (AJE) and Editage to provide discounted services to PLOS authors. Both organizations have experience helping authors meet PLOS guidelines and can provide language editing, translation, manuscript formatting, and figure formatting to ensure your manuscript meets our submission guidelines. To take advantage of our partnership with AJE, visit the AJE website (http://learn.aje.com/plos/) for a 15% discount off AJE services. To take advantage of our partnership with Editage, visit the Editage website (www.editage.com) and enter referral code PLOSEDIT for a 15% discount off Editage services. If the PLOS editorial team finds any language issues in text that either AJE or Editage has edited, the service provider will re-edit the text for free. Upon resubmission, please provide the following: ● The name of the colleague or the details of the professional service that edited your manuscript ● A copy of your manuscript showing your changes by either highlighting them or using track changes (uploaded as a supporting information file) ● A clean copy of the edited manuscript (uploaded as the new manuscript file) [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ________________________________________ 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ________________________________________ 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: Yes Reviewer #3: Yes ________________________________________ 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ________________________________________ 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The aim of this retrospective case series is to analyze the outcome of to continuous insulin infusion in hypertriglyceridemia-associated acute pancreatitis. It was concluded that continuous insulin infusion was effective in reducing serum triglyceride level in the majority of patients. Presence of diabetes, higher BMI and initial triglyceride slowed the time needed to effectively reduce serum triglyceride level. There are many case reports and series demonstrating the effectiveness of insulin in lowering triglyceride level. This study provides data about the quantity of insulin and the duration required to reduce effectively the serum triglyceride level. Criticisms: 1. Fasting and intravenous hydration applied in the treatment of acute pancreatitis rapidly and greatly reduces serum triglyceride level and can be as effective as intravenous insulin. Provide data about the applied intravenous fluid therapy in the first days of your patients. Intravenous hydration can be a confounding factor in this study. Please, discuss it. In our ICUs, such patients would receive IV fluids (either 0.9% or 0.45% saline) based on hydration parameters. We did not include these data since the IV fluid therapy is consistently implemented with hydration information added in the Methods section, page 4. 2. Was dextrose infusion applied as part of the parenteral fluid therapy in the study? Please, provide details in the Methods. There were no indications in the blood glucose data that any patients would have required dextrose infusions, therefore not mentioned in the Method section. 3. Could you give data about the severity and outcome of acute pancreatitis especially in the RP and NR, SRP and RRP group, respectively? This study was focused on the impact of CII on HTG reduction. Data to assess severity of AP were not collected. However, based on admission and discharge dates, all patients survived and were discharged home. Sentence added in Results, page 10. 4. What is the 75th percentile in this data from table 2? 4 [0.5] Fixed typo – 4 [0, 5] 5. Page 12: ‘Figure 1: Consort Table’. Some contradiction: is it a figure or table? ‘Patient’s flow chart’ is suggested to be used. Figure 1 title changed to Consort Chart 6. Page 22: ‘Figure 1’ is supposed to be Figure 2. What is the meaning of gosl? Please use the word time/Time, insulin/Insulin consistently. Figure 1 changed to Figure 2 and typos/inconsistencies fixed. 7. The style of references does not follow the requirements of the journal. Reference style updated. 8. There are many typos in the manuscript. Some of them: Abstract: kg/m2…instead of …kg/m 2… Abstract: …HbA1c… instead of …HbA1C… Page 10: …abdominal pain… instead of…. pain abdomen… Repeatedly:…. p = 0.130… instead of …p 0.130… Table 2 title: …. less than 36 hours vs 36 hours …instead of … less than vs 36 hours … Table 2:… 36 hours or more… instead of … 36 hours or More … Table 2: … (hours) … instead of … hours)… Typos corrected. Reviewer #2: 1. Please review abstract. Currently not able to be interpreted easily. Abstract revised. 2. "CII is an effective modality of therapy to reduce acutely the TG levels" - please review syntax Sentence on page 3 revised to: CII is an effective modality of therapy to reduce TG levels rapidly. 3. "AP was defined per Atlanta classification of acute pancreatitis 2012 as any two of the three following criteria: pain abdomen (acute onset, persistent, severe, epigastric pain often radiating to the back), pancreatic enzymes (serum lipase or amylase) level at least 3 times greater than the upper limit of normal, computed tomography (CT) or magnetic resonance imaging (MRI) evidence of acute pancreatitis" - please correct to abdominal pain Corrected. 4. Why were pregnant women excluded from this study? Pregnant women were excluded to eliminate pregnancy as a confounding variable. At the same time, no patients with pregnancy were in the initial study group prior to exclusion. In this study of acute pancreatitis, no pregnant patients with acute pancreatitis presented. 5. "Secondary outcomes were time durations to achieve TG-50% (half of the respective initial TG) and time durations to achieve TG-goal" - please take out durations Corrected. 6. What is your institution's protocol about rate and concentration of dextrose delivery? This will affect insulin doses No information about rate and concentration of dextrose delivery is needed so there were no indications in the blood glucose data that any patients would have required dextrose infusions. 7. "The four patients who did not reach TG-goal (NR, non-responders) had a long time to initiation of CII (3 [0, 5.5] vs 10 [2.2, 37.2] hr, p 0.130) but otherwise did not differ from RP" - p value suggests this is not significant As suggested, this statement was deleted. Reviewer #3: In this manuscript authors investigated efficacy of continuous insulin insfusion on lowering triglyceride levels in patients with hypertriglyceridemic pancreatitis. They also search for the factors that can predict treatment success. This study gives a new insight how insulin, as a triglyceride lowering agent, could be used in patients with hypertriglyceridemic pancreatitis and which parameters could help in titration of therapy. In the current literature this kind of data are lacking so this manuscript is of great importance from the clinical and research points of view. Introduction provides good and concise background of the topic. The objective is clearly defined. Methodology of the study is well designed but continuous insulin infusion protocol could be explained in a more detailed way (quantity of insulin in infusion, type and volume of solution, frequency of glucose checks, goal glucose levels and adjustment of infusion rate). More details were added to the Methods section, page 4. Other components of methodology, inclusion/exclusion criteria and outcomes are thoroughly written. Results are well presented. Tables and figures are clear, informative and easy to follow. The data provide enough evidence to make a conclusions. Discussion gives good perspective of current knowledge and how findings of this study can upgrade clinical practice. Conclusions are well presented and supported by the data. The literature cited is relevant to the study. ________________________________________ 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No Reviewer #3: No Attachments Attachment Submitted filename: PLOS One Reviewer Responses 10-22-21.docx https://doi.org/10.1371/journal.pone.0260495.r002
11 Nov 2021 Decision Letter - Zoltán Rakonczay Jr., Editor Hypertriglyceridemia-Associated Acute Pancreatitis: Response to Continuous Insulin Infusion PONE-D-21-25261R1 Dear Dr. Amblee, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Zoltán Rakonczay Jr., M.D., Ph.D., D.Sc. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #3: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #3: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know Reviewer #3: (No Response) ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #3: (No Response) ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #3: (No Response) ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: All required questions have been answered. All required questions have been answered. All required questions have been answered. All required questions have been answered. Reviewer #3: (No Response) ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #3: No https://doi.org/10.1371/journal.pone.0260495.r003
Formally Accepted
18 Nov 2021 Acceptance Letter - Zoltán Rakonczay Jr., Editor PONE-D-21-25261R1 Hypertriglyceridemia-Associated Acute Pancreatitis: Response to Continuous Insulin Infusion Dear Dr. Amblee: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Zoltán Rakonczay Jr. Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0260495.r004

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