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NCT Number: NCT05909722

Validation of the GIDS and Description of Phosphate Disorders

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tartu University Hospital

Tartu, Estonia

About this study

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:

  • Study period of a maximum of 7 days
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Phosphate levels

Primary outcomes

  1. 90 days mortality

    Time frame: 90 days

    Survival status at 90 days after ICU admission

  2. 28 days mortality

    Time frame: 28 days

    Survival status at 28 days after ICU admission

Secondary outcomes

  1. Days free of organ support

    Time frame: 28 days

    Days alive and free of organ support (including parenteral nutrition-free days) by day 28

  2. Prevalence of phosphate disorders at ICU admission

    Time frame: Day of ICU admission (day 1)

    Prevalence of hypo- and hyperphosphatemia on ICU admission

  3. Incidence of phosphate disorders during seven days of ICU stay

    Time frame: 7 days

    Incidence of hypo- and hyperphosphatemia during seven days of ICU stay

  4. The amount of phosphate administered

    Time frame: 7 days

    The amount of phosphate administered to patients with hypophosphatemia

  5. Change in serum phosphate level in response to phosphate supplementation

    Time frame: 7 days

    Chenge in serum phosphate level in response to phosphate supplementation (correction/overcorrection/no correction)

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Mar 25, 2025

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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