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NCT Number: NCT06376461

Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients

Part A Multiple organ dysfunction syndrome is one of the main problems in critically ill patients. Several organ dysfunctions are routinely and systematically monitored in patients admitted to intensive care units. Gastrointestinal dysfunction is currently not included in multiple organ dysfunction scores and lacks a standardised approach. At the same time, investigators earlier studies have shown that gastrointestinal dysfunction plays an essential role in the course of illness in intensive care patients. A tool for measuring dysfunction is needed to enable future studies on interventions to improve gastrointestinal function. The GIDS (GastroIntestinal Dysfunction Score) combines different clinical signs and symptoms commonly observed and documented in patients in the ICU into a scoring system, allowing distinguishing between different grades of severity of dysfunction. The investigators will only use observations documented during the patient's stay in the intensive care unit without additional measurements and calculate gastrointestinal (GIDS) and other organ dysfunction scores.

Part B Phosphate is an electrolyte commonly measured and often corrected, while the indications and clear guidance for correction are insufficiently studied. The results of this study will assist in specifying indications for the correction of phosphate levels better and refine the management strategies in the future. Only phosphate levels measured as part of routine care will be documented, no additional samples for study purposes will be taken, and the study will not influence the treatment of phosphate disorders.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

Who can participate

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

Inclusion criteria

  • Admission to ICU during the study period (the patients already in the ICU at the time the study starts will not be included);
  • Age ≥18 years;
  • In participating centres in part B, serum Pi should be measured daily.

Exclusion criteria

  • Age <18 years;
  • Patients with restrictions of care such as "no intubation" or "no RRT" 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

Data Collection

Other

Sites will recruit all consecutive adult patients admitted to ICU, to a maximum of 120 patients or a maximum recruitment period of 8 weeks, whichever comes first

Primary outcomes

  1. 28 day outcome

    Time frame: 28 days after ICU admission

    28 day all cause mortality

  2. 90 day outcome

    Time frame: 90 days after ICU admission

    90 day all cause mortality

Secondary outcomes

  1. ICU length of stay

    Time frame: 28 days after admission to ICU

    ICU length of stay/days alive and free of ICU by day 28

  2. ICU length of stay

    Time frame: 90 days after admission to ICU

    ICU length of stay/days alive and free of ICU by day 90

  3. Hospital length of stay

    Time frame: 28 days after admission

    Hospital length of stay/days alive and free of hospital by day 28

  4. Hospital length of stay

    Time frame: 90 days after admission

    Hospital length of stay/days alive and free of hospital by day 90

  5. Free of organ support

    Time frame: 28 days after admission

    Days alive and free of organ support (including PN free days) by day 28

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Acronym: GUTPHOS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2024
Registry last updated
Jul 3, 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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