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. 2024 Oct:63:702-708.
doi: 10.1016/j.clnesp.2024.07.023. Epub 2024 Jul 26.

Prospective multicenter study to validate the gastrointestinal dysfunction score (GIDS) in intensive care patients: Study protocol for Part A of the international GUTPHOS study

Imre W K Kouw  1 , Max Melchers  2 , Merli Mändul  3 , Yaseen M Arabi  4 , Michael P Casaer  5 , Antonella Cotoia  6 , Jan Gunst  7 , Manu L N G Malbrain  8 , Stefan J Schaller  9 , Joel Starkopf  10 , Martin Sundström Rehal  11 , Annika Reintam Blaser  12 , Arthur R H van Zanten  13
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Free article

Prospective multicenter study to validate the gastrointestinal dysfunction score (GIDS) in intensive care patients: Study protocol for Part A of the international GUTPHOS study

Imre W K Kouw et al. Clin Nutr ESPEN. 2024 Oct.
Free article

Abstract

Background: While gastrointestinal (GI) dysfunction is commonly encountered among critically ill patients, a uniform prospectively validated scoring system is lacking. The present study aims to validate the recently developed Gastrointestinal Dysfunction Score (GIDS) in a multicenter, prospective cohort of consecutive adult patients admitted to intensive care units (ICU).

Methods: GUTPHOS is a prospective, multicenter, non-interventional cohort study in which at least 1400 consecutive adult patients (age ≥18 years) admitted to the ICU will be monitored daily for abdominal signs and symptoms of GI dysfunction. The previously developed GIDS constructed from these signs and symptoms will be tested in relation to mortality and duration of ICU dependency and parenteral nutrition (PN) dependency. Between January and June 2024, each participating clinical site will include 50-120 consecutive patients over an eight-week period. Study data will be collected in three phases: baseline data upon ICU admission, daily observations throughout a maximum of 7 days in ICU or until discharge, and a follow-up period of 90 days. The primary outcomes are 28- and 90-day all-cause mortality. Secondary outcomes include ICU and hospital mortality, ICU and hospital length of stay, days alive and free of ICU by day 28 and day 90, days alive and free of hospital by day 28 and day 90, and days alive and free of organ support and PN dependency by day 28.

Discussion: The GUTPHOS study will be the first worldwide, multicenter, prospective, observational cohort study to validate the GIDS in adult patients admitted to ICUs against 28- and 90-day mortality. The availability of a validated tool will allow its use in interventional studies that are currently hindered by the lack of a validated measurement tool for GI dysfunction.

Clinical trial registry: NCT05909722.

Keywords: Critical illness; GIDS; Gastrointestinal dysfunction; Intensive care; Nutrition; iSOFA.

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Conflict of interest statement

Declaration of competing interest IWKK received a Veni Fellowship (2024–2028) through the Dutch Research Council (NWO Talent Program). SJS received grants and non-financial support from Reactive Robotics GmbH (Munich, Germany), ASP GmbH (Attendorn, Germany), STIMIT AG (Biel, Switzerland), ESICM (Geneva, Switzerland), grants, personal fees, and non-financial support from Fresenius Kabi Deutschland GmbH (Bad Homburg, Germany), grants from the Innovationsfond of The Federal Joint Committee (G-BA), personal fees from Springer Verlag GmbH (Vienna, Austria) for educational purposes and Advanz Pharma GmbH (Bielefeld, Germany), non-financial support from national and international societies (and their congress organizers) in the field of anesthesiology and intensive care medicine, outside the submitted work. SJS holds stocks in small amounts from Alphabet Inc., Bayer AG, and Siemens AG; these holdings have not affected any decisions regarding his research or this study. ARHvZ reported receiving honoraria for advisory board meetings, lectures, research, and travel expenses from Abbott, AOP Pharma, Baxter, Cardinal Health, Danone-Nutricia, Fresenius Kabi, GE Healthcare, Medcaptain, Nestlé, PAION, and Rousselot. ARB received speaker or consulting fees from Nutricia and VIPUN Medical. JG is granted a senior clinical investigator fellowship by Research Foundation – Flanders (1842724N) and has obtained research funding through grants from KU Leuven (STG/23/032) and the European Society of Intensive Care Medicine (Fundamental Research Award 2022). MPC has obtained research funding by grants from Research Foundation Flanders, KU Leuven and Department for Innovation of the Flanders Government, and reported receiving consulting fees from Baxter and VIPUN. MLNGM reported receiving honoraria for advisory board meetings, lectures, research, and travel expenses from Getinge, Serenno Medical, Potrero Medical, Sentinel Medical, Baxter, BBraun, Becton Dickinson, ConvaTec, Spiegelberg, Medtronic, MedCaptain, and Holtech Medical, and PeerVoice. He holds stock options for Sentinel, Serenno and Potrero. The other authors declare no competing interests.

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