NCT05909722

Validation of the GIDS and Description of Phosphate Disorders

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,681 (actual)
• Sponsor: University of Tartu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

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.

Conditions

• Organ Dysfunction Scores
• Hypophosphatemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Gastrointestinal Dysfunction Score will be calculated	We collect routine daily data on GI signs and symptoms and calculate the score (GIDS). We collect serum phosphate values as measured in routine practice of participating sites.

Timeline

• Start date: 2024-01-08
• Primary completion: 2024-12-20
• Completion: 2024-12-20
• First posted: 2023-06-18
• Last updated: 2025-03-25

Locations

1 site across 1 country: Estonia