Tartu University Hospital
Tartu, Estonia
NCT Number: NCT05909722
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.
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Notify Me18 year and older
All sexes
Observational
Tartu, Estonia
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:
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We collect routine daily data on GI signs and symptoms and calculate the score (GIDS). We collect serum phosphate values as measured in routine practice of participating sites.
Other names: Phosphate levels
Time frame: 90 days
Survival status at 90 days after ICU admission
Time frame: 28 days
Survival status at 28 days after ICU admission
Time frame: 28 days
Days alive and free of organ support (including parenteral nutrition-free days) by day 28
Time frame: Day of ICU admission (day 1)
Prevalence of hypo- and hyperphosphatemia on ICU admission
Time frame: 7 days
Incidence of hypo- and hyperphosphatemia during seven days of ICU stay
Time frame: 7 days
The amount of phosphate administered to patients with hypophosphatemia
Time frame: 7 days
Chenge in serum phosphate level in response to phosphate supplementation (correction/overcorrection/no correction)
University of Tartu
Other
Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients
Acronym: GUTPHOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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