Article Text

Download PDFPDF

Ward-based Goal-Directed Fluid Therapy (GDFT) in Acute Pancreatitis (GAP) trial: study protocol for a feasibility randomised controlled trial
  1. Farid Froghi1,2,
  2. Fiammetta Soggiu2,
  3. Federico Ricciardi3,
  4. Kurinchi Gurusamy1,
  5. Daniel S Martin1,4,
  6. Jeshika Singh5,
  7. Sulman Siddique1,
  8. Christine Eastgate4,
  9. Maria Ciaponi4,
  10. Margaret McNeil4,
  11. Helder Filipe4,
  12. Otto Schwalowsky-Monks4,
  13. Gretchelle Asis4,
  14. Massimo Varcada6,
  15. Brian R Davidson2
  1. 1 Division of Surgery and Interventional Science, University College London, London, UK
  2. 2 HPB and Liver Transplantation Surgery, Royal Free Hospital, London, UK
  3. 3 Statistical Sciences, University College London, London, UK
  4. 4 Critical Care Unit, Royal Free Hospital, London, UK
  5. 5 Health Economics, PHMR, London, UK
  6. 6 General and Emergency Surgery, Royal Free Hospital, London, UK
  1. Correspondence to Farid Froghi; farid.froghi{at}nhs.net

Abstract

Introduction Acute pancreatitis is an inflammatory disease of the pancreas with high risk of developing multiorgan failure and death. There are no effective pharmacological interventions used in current clinical practice. Maintaining fluid and electrolyte balance is the mainstay of supportive management. Goal-directed fluid therapy (GDFT) has been shown to decrease morbidity and mortality in surgical conditions with systemic inflammatory response. There is currently no randomised controlled trial (RCT) investigating the role of GDFT based on cardiac output parameters in patients with acute pancreatitis in the ward setting. A feasibility trial was designed to determine patient and clinician support for recruitment into an RCT of ward-based GDFT in acute pancreatitis, adherence to a GDFT protocol, safety, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate efficacy.

Methods and analysis The GDFT in Acute Pancreatitis trial is a prospective two-centre feasibility RCT. Eligible adults admitted with new onset of acute pancreatitis will be enrolled and randomised into ward-based GDFT (n=25) or standard fluid therapy (n=25) within 6 hours from the diagnosis and continuing for the following 48 hours. Cardiac output parameters will be monitored with a non-invasive device (Cheetah NICOM; Cheetah Medical). The intervention group will consist of a protocolised GDFT approach consisting of stroke volume optimisation with crystalloid fluid boluses, while the control group will receive standard care fluid therapy as advised by the clinical team. The primary endpoint is feasibility. Secondary endpoints will include safety of the intervention, complications, mortality, admission to intensive care unit, cost and quality of life.

Ethics and dissemination Ethics approval was granted by the London Central Research Ethics Committee (17/LO/1235, project ID: 221872). The results of this trial will be presented to international conference with interest in general surgery and acute care and published in a peer-reviewed journal.

Trial registration number ISRCTN36077283.

  • fluid therapy
  • acute pancreatitis
  • cardiac output
  • goal-directed fluid therapy

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

View Full Text

Statistics from Altmetric.com

Footnotes

  • Twitter @drfroghi

  • Contributors FF: manuscript preparation, mechanistic components of protocol design, trial and database management. FS: manuscript preparation, trial management. FR: statistical analysis plan. KG: major contribution to design and funding application. DSM: protocol design of GDFT regimes, trial management. SS: initial protocol developments and ethical approvals. CE, MC, OSM, GA, MM and HF: trial research nurses trained in delivering GDFT, data collection. JS: health economic analysis design. MV: participant enrolment planning through emergency surgery. BRD: principal investigator and grant holder, overall trial management, study design and review of manuscript. All authors read and approved the final manuscript.

  • Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) programme (Grant Reference No PB-PG-0815-20002).

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The trial protocol (v2) has been reviewed and approved by the London Central Research Ethics Committee (REC Ref: 17/LO/1235, project ID: 221872). Informed consent will be obtained from eligible patients after screening by a member of the research or clinical team trained in Good Clinical Practice (GCP). The trial has been registered on ISRCTN on 9 April 2018 (http://www.isrctn.com/ISRCTN36077283). The results of this study will be presented to the national and international meetings with interest in the management of acute pancreatitis and prepared for publication in peer-reviewed journals with a readership in general surgery and critical care.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.