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

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06376461
Acronym
GUTPHOS
Enrollment
92
Registered
2024-04-19
Start date
2024-07-26
Completion date
2025-06-26
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Dysfunction

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.

Interventions

OTHERData collection

Sites will recruit all consecutive adult patients admitted to ICU, to a maximum of 120 patients or a maximum recruitment period of 8 weeks, whichever comes first

Sponsors

University Hospitals of North Midlands NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
28 day outcome28 days after ICU admission28 day all cause mortality
90 day outcome90 days after ICU admission90 day all cause mortality

Secondary

MeasureTime frameDescription
ICU length of stay28 days after admission to ICUICU length of stay/days alive and free of ICU by day 28
Hospital length of stay28 days after admissionHospital length of stay/days alive and free of hospital by day 28
Free of organ support28 days after admissionDays alive and free of organ support (including PN free days) by day 28

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026