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

Recruiting

• Conditions: Gastrointestinal Dysfunction

• Registration Number: NCT06376461
• Lead Sponsor: University Hospitals of North Midlands NHS Trust

Brief Summary

Part A Multiple organ dysfunction syndrome is one of the main problems in critically ill patients. Several organ dysfunctions are routinely and systematically monitored in patients admitted to intensive care units. Gastrointestinal dysfunction is currently not included in multiple organ dysfunction scores and lacks a standardised approach. At the same time, investigators earlier studies have shown that gastrointestinal dysfunction plays an essential role in the course of illness in intensive care patients. A tool for measuring dysfunction is needed to enable future studies on interventions to improve gastrointestinal function. The GIDS (GastroIntestinal Dysfunction Score) combines different clinical signs and symptoms commonly observed and documented in patients in the ICU into a scoring system, allowing distinguishing between different grades of severity of dysfunction. The investigators will only use observations documented during the patient's stay in the intensive care unit without additional measurements and calculate gastrointestinal (GIDS) and other organ dysfunction scores.

Part B Phosphate is an electrolyte commonly measured and often corrected, while the indications and clear guidance for correction are insufficiently studied. The results of this study will assist in specifying indications for the correction of phosphate levels better and refine the management strategies in the future. Only phosphate levels measured as part of routine care will be documented, no additional samples for study purposes will be taken, and the study will not influence the treatment of phosphate disorders.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Study Start: 2024-07-26
• Primary Completion: 2025-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Admission to ICU during the study period (the patients already in the ICU at the time the study starts will not be included);
• Age ≥18 years;
• In participating centres in part B, serum Pi should be measured daily.

Exclusion Criteria

• Age <18 years;
• Patients with restrictions of care such as "no intubation" or "no RRT" 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28 day outcome	28 days after ICU admission	28 day all cause mortality
90 day outcome	90 days after ICU admission	90 day all cause mortality

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	90 days after admission	Hospital length of stay/days alive and free of hospital by day 90
ICU length of stay	90 days after admission to ICU	ICU length of stay/days alive and free of ICU by day 90
Free of organ support	28 days after admission	Days alive and free of organ support (including PN free days) by day 28

Trial Locations

Locations (1)

University Hospitals of North Midlands NHS Trust; 🇬🇧 Stoke-on-Trent, United Kingdom