Study Protocol for RESORP – Resolution of Organ Injury in Acute Pancreatitis – an observational prospective cohort study

Ahmed E Sherif; Rory McFadyen; Julia Boyd; Chiara  Ventre; Margaret Glenwright; Kim Walker; Xiaozhong Zheng; Audrey White; Laura McFadyen; Emma Connon; Dimitrios Damaskos; Michelle Steven; Anthony  Wackett; Euan Thomson; David C Cameron; Scott I K Semple; David Morris; Saskia Clark-Stewart; Catriona  Graham; Damian J Mole

doi:10.1136/bmjopen-2020-040200

Study Protocol for RESORP – Resolution of Organ Injury in Acute Pancreatitis – an observational prospective cohort study

Ahmed E Sherif, Rory McFadyen, Julia Boyd, Chiara Ventre, Margaret Glenwright, Kim Walker, Xiaozhong Zheng, Audrey White, Laura McFadyen, Emma Connon, Dimitrios Damaskos, Michelle Steven, Anthony Wackett, Euan Thomson, David C Cameron, Scott I K Semple, David Morris, Saskia Clark-Stewart, Catriona Graham, Damian J Mole

Research output: Contribution to journal › Article › peer-review

Abstract

Introduction: Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared to the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP.
Methods and Analysis
This is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus, and quality of life. Recruitment was from 30th November 2017 to 31st May 2020; last follow-up measurements is due 31st May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, GIQLI); Montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis.
Ethics and dissemination: This study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access.
Trial registration: ClinicalTrials.gov Identifier (NCT03342716) and ISRCTN 50581876; Pre-results

Original language	English
Journal	BMJ Open
DOIs	https://doi.org/10.1136/bmjopen-2020-040200
Publication status	Published - 7 Dec 2020

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10.1136/bmjopen-2020-040200

e040200.full
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Premature death and organ hypofunction after severe acute pancreatitis results from cellular senescence - mechanisms and new opportunities for therapy
Mole, D. (Principal Investigator)
MRC
1/02/17 → 31/01/23
Project: Research

Edinburgh Imaging Facility
Grant, A. (Manager), van Beek, E. (Manager) & Semple, S. (Manager)
Deanery of Clinical Sciences
Facility/equipment: Facility

Cite this

Sherif, A. E., McFadyen, R., Boyd, J., Ventre, C., Glenwright, M., Walker, K., Zheng, X., White, A., McFadyen, L., Connon, E., Damaskos, D., Steven, M., Wackett, A., Thomson, E., Cameron, D. C., Semple, S. I. K., Morris, D., Clark-Stewart, S., Graham, C., & Mole, D. J. (2020). Study Protocol for RESORP – Resolution of Organ Injury in Acute Pancreatitis – an observational prospective cohort study. BMJ Open. https://doi.org/10.1136/bmjopen-2020-040200

@article{b848f36559a642fe8b13c997d27c97b7,

title = "Study Protocol for RESORP – Resolution of Organ Injury in Acute Pancreatitis – an observational prospective cohort study",

abstract = "Introduction: Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared to the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP.Methods and AnalysisThis is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus, and quality of life. Recruitment was from 30th November 2017 to 31st May 2020; last follow-up measurements is due 31st May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, GIQLI); Montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis.Ethics and dissemination: This study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access.Trial registration: ClinicalTrials.gov Identifier (NCT03342716) and ISRCTN 50581876; Pre-results",

author = "Sherif, {Ahmed E} and Rory McFadyen and Julia Boyd and Chiara Ventre and Margaret Glenwright and Kim Walker and Xiaozhong Zheng and Audrey White and Laura McFadyen and Emma Connon and Dimitrios Damaskos and Michelle Steven and Anthony Wackett and Euan Thomson and Cameron, {David C} and Semple, {Scott I K} and David Morris and Saskia Clark-Stewart and Catriona Graham and Mole, {Damian J}",

year = "2020",

month = dec,

day = "7",

doi = "10.1136/bmjopen-2020-040200",

language = "English",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

}

Sherif, AE, McFadyen, R, Boyd, J, Ventre, C, Glenwright, M, Walker, K, Zheng, X, White, A, McFadyen, L, Connon, E, Damaskos, D, Steven, M, Wackett, A, Thomson, E, Cameron, DC, Semple, SIK, Morris, D, Clark-Stewart, S, Graham, C & Mole, DJ 2020, 'Study Protocol for RESORP – Resolution of Organ Injury in Acute Pancreatitis – an observational prospective cohort study', BMJ Open. https://doi.org/10.1136/bmjopen-2020-040200

TY - JOUR

T1 - Study Protocol for RESORP – Resolution of Organ Injury in Acute Pancreatitis – an observational prospective cohort study

AU - Sherif, Ahmed E

AU - McFadyen, Rory

AU - Boyd, Julia

AU - Ventre, Chiara

AU - Glenwright, Margaret

AU - Walker, Kim

AU - Zheng, Xiaozhong

AU - White, Audrey

AU - McFadyen, Laura

AU - Connon, Emma

AU - Damaskos, Dimitrios

AU - Steven, Michelle

AU - Wackett, Anthony

AU - Thomson, Euan

AU - Cameron, David C

AU - Semple, Scott I K

AU - Morris, David

AU - Clark-Stewart, Saskia

AU - Graham, Catriona

AU - Mole, Damian J

PY - 2020/12/7

Y1 - 2020/12/7

N2 - Introduction: Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared to the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP.Methods and AnalysisThis is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus, and quality of life. Recruitment was from 30th November 2017 to 31st May 2020; last follow-up measurements is due 31st May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, GIQLI); Montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis.Ethics and dissemination: This study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access.Trial registration: ClinicalTrials.gov Identifier (NCT03342716) and ISRCTN 50581876; Pre-results

AB - Introduction: Survivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared to the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP.Methods and AnalysisThis is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus, and quality of life. Recruitment was from 30th November 2017 to 31st May 2020; last follow-up measurements is due 31st May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, GIQLI); Montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis.Ethics and dissemination: This study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access.Trial registration: ClinicalTrials.gov Identifier (NCT03342716) and ISRCTN 50581876; Pre-results

U2 - 10.1136/bmjopen-2020-040200

DO - 10.1136/bmjopen-2020-040200

M3 - Article

SN - 2044-6055

JO - BMJ Open

JF - BMJ Open

ER -

Study Protocol for RESORP – Resolution of Organ Injury in Acute Pancreatitis – an observational prospective cohort study

Abstract

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Premature death and organ hypofunction after severe acute pancreatitis results from cellular senescence - mechanisms and new opportunities for therapy

Equipment

Edinburgh Imaging Facility

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