Validation of the GIDS and Description of Phosphate Disorders

NCT05909722 | Completed

• 1 other identifier: GUTPHOS study
• Study Type: observational
• Target: 2,681
• Locations: 1 country
• Sites: 1

Brief Summary

This study will address two specific research questions simultaneously:

1. 1.validation of the GastroIntestinal (GI) Dysfunction score (GIDS).
2. 2.description of epidemiology, risk factors, and management of phosphate disorders.

Conditions

Organ Dysfunction Scores; Hypophosphatemia

Outcome Measures

Primary Outcomes (2)

• 90 days mortality

  Survival status at 90 days after ICU admission

  90 days

• 28 days mortality

  Survival status at 28 days after ICU admission

  28 days

Secondary Outcomes (5)

• Days free of organ support

  28 days

• Prevalence of phosphate disorders at ICU admission

  Day of ICU admission (day 1)

• Incidence of phosphate disorders during seven days of ICU stay

  7 days

• The amount of phosphate administered

  7 days

• Change in serum phosphate level in response to phosphate supplementation

  7 days

Interventions

Gastrointestinal Dysfunction Score will be calculated DIAGNOSTIC_TEST

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.

Also known as: Phosphate levels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive adult patients that are admitted to participating ICU during a recruitment period of maximum 8 weeks. In all included patients data on organ dysfunctions will be collected, in patients from sites with routine serum phosphate measurements additional data on phosphate values and management will be collected (inclusion in the Phosphate part of the study).

You may qualify if:

• Admission to ICU during the study period
• Age ≥18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (1)

Tartu University Hospital

Tartu, Estonia

Location

Related Publications (3)

• 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.

  PMID: 34358839 BACKGROUND

• Melchers M, Kouw IWK, Arabi YM, Casaer MP, Cotoia A, Gunst J, Malbrain MLNG, Schaller SJ, Starkopf J, Rehal MS, Blaser AR, van Zanten ARH. Prospective multicenter study to describe the prevalence, outcomes, and management of phosphate disorders in intensive care patients: Study protocol for part B of the international GUTPHOS study. Clin Nutr ESPEN. 2024 Oct;63:681-687. doi: 10.1016/j.clnesp.2024.07.024. Epub 2024 Jul 26.

  PMID: 39069259 DERIVED

• Kouw IWK, Melchers M, Mandul M, Arabi YM, Casaer MP, Cotoia A, Gunst J, Malbrain MLNG, Schaller SJ, Starkopf J, Sundstrom Rehal M, Reintam Blaser A, van Zanten ARH. Prospective multicenter study to validate the gastrointestinal dysfunction score (GIDS) in intensive care patients: Study protocol for Part A of the international GUTPHOS study. Clin Nutr ESPEN. 2024 Oct;63:702-708. doi: 10.1016/j.clnesp.2024.07.023. Epub 2024 Jul 26.

  PMID: 39069258 DERIVED

MeSH Terms

Conditions

Hypophosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Arthur van Zanten, PhD

  Gelderse Valley Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 18, 2023
• Study Start: January 8, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

ES (1)