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

Gastrointestinal Dysfunction Clinical Trial

— GUTPHOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376461
• Other study ID #: 333874
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University Hospitals of North Midlands NHS Trust
• Contact: Megan Young
• Phone: 01782 675384
• Email: megan.young[@]uhnm.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Dysfunction

Intervention

Other:
• Data 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

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 day outcome	28 day all cause mortality	28 days after ICU admission
Primary	90 day outcome	90 day all cause mortality	90 days after ICU admission
Secondary	ICU length of stay	ICU length of stay/days alive and free of ICU by day 28	28 days after admission to ICU
Secondary	ICU length of stay	ICU length of stay/days alive and free of ICU by day 90	90 days after admission to ICU
Secondary	Hospital length of stay	Hospital length of stay/days alive and free of hospital by day 28	28 days after admission
Secondary	Hospital length of stay	Hospital length of stay/days alive and free of hospital by day 90	90 days after admission
Secondary	Free of organ support	Days alive and free of organ support (including PN free days) by day 28	28 days after admission