Validation of the GIDS and Description of Phosphate Disorders (GUTPHOS)

Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients

This study will address two specific research questions simultaneously:

1. validation of the GastroIntestinal (GI) Dysfunction score (GIDS).
2. description of epidemiology, risk factors, and management of phosphate disorders.

The aim is to recruit 20 ICUs and 1500 ICU patients. Sites will recruit all consecutive adult patients to a maximum of 120 patients or a maximum recruitment period of 8 weeks, whichever comes first. Daily data collection on gastrointestinal signs and symptoms as well as phosphate values and management will be collected during ICU stay for maximum of 7 days. 28 and 90 day mortality and days free of organ support will be the main outcomes. Secondary outcomes include prevalence of hypo- and hyperphosphatemia and description of their management.

Study Overview

• Status: Completed
• Conditions: Hypophosphatemia; Organ Dysfunction Scores
• Intervention / Treatment: Diagnostic test: Gastrointestinal Dysfunction Score will be calculated

Detailed Description

Patient population All consecutive adult patients that are admitted to participating ICU during a recruitment period of maximum 8 weeks.

Duration of the study for the individual patient:

1. Study period of a maximum of 7 days
2. Follow-up period of a maximum of 90 days All patients will be included in the Part A of the study validating GIDS, patients from sites with routine serum phosphate measurements will be included also in the Part B of the study where additional data on serum phosphate levels and management of phosphate disorders will be collected. There will be no additional measurements due to study participation, daily routine is documented.

Baseline characteristics will be collected at ICU admission/study inclusion Daily data include routine data on organ dysfunctions and organ support therapies and specific data on phosphate where available.

Outcome data include 28 and 90 days mortality, and days free of organ support by day 28.

• Study Type: Observational
• Enrollment (Actual): 2681

Contacts and Locations

Study Locations

• Estonia
  • Tartu, Estonia
    • Tartu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All consecutive adult patients that are admitted to participating ICU during a recruitment period of maximum 8 weeks. In all included patients data on organ dysfunctions will be collected, in patients from sites with routine serum phosphate measurements additional data on phosphate values and management will be collected (inclusion in the Phosphate part of the study).

Description

Inclusion Criteria:

• Admission to ICU during the study period
• Age ≥18 years

Exclusion Criteria:

• Age <18 years;
• Patients with restrictions of care such as "no intubation" or "no renal replacement therapy" on ICU admission and patients admitted for treatment as organ donors;
• Continuous chronic home ventilation for neuromuscular disease;
• Declined participation or informed consent (if the local ethics committee requests the latter for this non-interventional study);
• Readmission to ICU during the study period

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90 days mortality	Survival status at 90 days after ICU admission	90 days
28 days mortality	Survival status at 28 days after ICU admission	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days free of organ support	Days alive and free of organ support (including parenteral nutrition-free days) by day 28	28 days
Prevalence of phosphate disorders at ICU admission	Prevalence of hypo- and hyperphosphatemia on ICU admission	Day of ICU admission (day 1)
Incidence of phosphate disorders during seven days of ICU stay	Incidence of hypo- and hyperphosphatemia during seven days of ICU stay	7 days
The amount of phosphate administered	The amount of phosphate administered to patients with hypophosphatemia	7 days
Change in serum phosphate level in response to phosphate supplementation	Chenge in serum phosphate level in response to phosphate supplementation (correction/overcorrection/no correction)	7 days

Collaborators and Investigators

• Sponsor: University of Tartu
• Investigators: Principal Investigator: Arthur van Zanten, PhD, Gelderse Valley Hospital

Publications and helpful links

General Publications

• Reintam Blaser A, Padar M, Mandul M, Elke G, Engel C, Fischer K, Giabicani M, Gold T, Hess B, Hiesmayr M, Jakob SM, Loudet CI, Meesters DM, Mongkolpun W, Paugam-Burtz C, Poeze M, Preiser JC, Renberg M, Rooijackers O, Tamme K, Wernerman J, Starkopf J. Development of the Gastrointestinal Dysfunction Score (GIDS) for critically ill patients - A prospective multicenter observational study (iSOFA study). Clin Nutr. 2021 Aug;40(8):4932-4940. doi: 10.1016/j.clnu.2021.07.015. Epub 2021 Jul 18.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hypophosphatemia
• Other Study ID Numbers: GUTPHOS study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No