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Clinical Trial Summary

This study will address two specific research questions simultaneously: 1. validation of the GastroIntestinal (GI) Dysfunction score (GIDS). 2. description of epidemiology, risk factors, and management of phosphate disorders. The aim is to recruit 20 ICUs and 1500 ICU patients. Sites will recruit all consecutive adult patients to a maximum of 120 patients or a maximum recruitment period of 8 weeks, whichever comes first. Daily data collection on gastrointestinal signs and symptoms as well as phosphate values and management will be collected during ICU stay for maximum of 7 days. 28 and 90 day mortality and days free of organ support will be the main outcomes. Secondary outcomes include prevalence of hypo- and hyperphosphatemia and description of their management.


Clinical Trial Description

Patient population All consecutive adult patients that are admitted to participating ICU during a recruitment period of maximum 8 weeks. Duration of the study for the individual patient: 1. Study period of a maximum of 7 days 2. Follow-up period of a maximum of 90 days All patients will be included in the Part A of the study validating GIDS, patients from sites with routine serum phosphate measurements will be included also in the Part B of the study where additional data on serum phosphate levels and management of phosphate disorders will be collected. There will be no additional measurements due to study participation, daily routine is documented. Baseline characteristics will be collected at ICU admission/study inclusion Daily data include routine data on organ dysfunctions and organ support therapies and specific data on phosphate where available. Outcome data include 28 and 90 days mortality, and days free of organ support by day 28. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05909722
Study type Observational
Source University of Tartu
Contact Annika Reintam Blaser, PhD
Phone +3725142281
Email annika.reintam.blaser@ut.ee
Status Recruiting
Phase
Start date January 8, 2024
Completion date December 20, 2024

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