Validation of a scoring system for gastrointestinal dysfunction in ICU patients
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 is testing a new scoring system to see how well it can help doctors track and manage gastrointestinal problems in patients who are critically ill in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals of North Midlands NHS Trust Academic / other |
| Locations | 1 site (Stoke-on-Trent) |
| Trial ID | NCT06376461 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the GastroIntestinal Dysfunction Score (GIDS) and assess the prevalence, outcomes, and management of phosphate disorders in patients admitted to intensive care units (ICUs). By systematically documenting clinical signs and symptoms of gastrointestinal dysfunction, the study seeks to establish a standardized approach to monitor this often-overlooked aspect of multiple organ dysfunction syndrome. Data will be collected from patients during their ICU stay, focusing on those who are newly admitted and meet specific eligibility criteria. The findings could pave the way for future interventions aimed at improving gastrointestinal function in critically ill patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older who are newly admitted to the ICU during the study period.
Not a fit: Patients under 18 years old, those with restrictions on care, or those who are readmitted to the ICU will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of gastrointestinal dysfunction in ICU patients, potentially enhancing patient outcomes.
How similar studies have performed: While gastrointestinal dysfunction is a recognized issue in critically ill patients, this specific scoring system is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stoke-on-Trent
- University Hospitals of North Midlands NHS Trust — Stoke-on-Trent, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Aviva Ogbolosingha
- Email: aviva.ogbolosingha@uhnm.nhs.uk
- Phone: 01782 675380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.