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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Dysfunction
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• United Kingdom
  • Stoke-on-Trent, United Kingdom
    • University Hospitals of North Midlands NHS Trust

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the ICU within in the recruitment period will be recruited to the trial.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28 day outcome	28 day all cause mortality	28 days after ICU admission
90 day outcome	90 day all cause mortality	90 days after ICU admission

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospitals of North Midlands NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 333874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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