Validation of the GIDS and Description of Phosphate Disorders

Hypophosphatemia 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: Recruiting

Administrative data

• NCT number: NCT05909722
• Other study ID #: GUTPHOS study
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: December 20, 2024

Study information

• Verified date: January 2024
• Source: University of Tartu
• Contact: Annika Reintam Blaser, PhD
• Phone: +3725142281
• Email: annika.reintam.blaser[@]ut.ee
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to ICU during the study period

• Age =18 years

Exclusion Criteria:

• Age <18 years;

• Patients with restrictions of care such as "no intubation" or "no renal replacement therapy" 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

• Hypophosphatemia

Intervention

Diagnostic Test:
• Gastrointestinal Dysfunction Score will be calculated
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.

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Country where clinical trial is conducted

Estonia, 

References & Publications (1)

Reintam Blaser A, Padar M, Mandul M, Elke G, Engel C, Fischer K, Giabicani M, Gold T, Hess B, Hiesmayr M, Jakob SM, Loudet CI, Meesters DM, Mongkolpun W, Paugam-Burtz C, Poeze M, Preiser JC, Renberg M, Rooijackers O, Tamme K, Wernerman J, Starkopf J. Development of the Gastrointestinal Dysfunction Score (GIDS) for critically ill patients - A prospective multicenter observational study (iSOFA study). Clin Nutr. 2021 Aug;40(8):4932-4940. doi: 10.1016/j.clnu.2021.07.015. Epub 2021 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90 days mortality	Survival status at 90 days after ICU admission	90 days
Primary	28 days mortality	Survival status at 28 days after ICU admission	28 days
Secondary	Days free of organ support	Days alive and free of organ support (including parenteral nutrition-free days) by day 28	28 days
Secondary	Prevalence of phosphate disorders at ICU admission	Prevalence of hypo- and hyperphosphatemia on ICU admission	Day of ICU admission (day 1)
Secondary	Incidence of phosphate disorders during seven days of ICU stay	Incidence of hypo- and hyperphosphatemia during seven days of ICU stay	7 days
Secondary	The amount of phosphate administered	The amount of phosphate administered to patients with hypophosphatemia	7 days
Secondary	Change in serum phosphate level in response to phosphate supplementation	Chenge in serum phosphate level in response to phosphate supplementation (correction/overcorrection/no correction)	7 days