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

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Stoke-on-Trent, United Kingdom
        • University Hospitals of North Midlands NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the ICU within in the recruitment period will be recruited to the trial.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 day outcome
Time Frame: 28 days after ICU admission
28 day all cause mortality
28 days after ICU admission
90 day outcome
Time Frame: 90 days after ICU admission
90 day all cause mortality
90 days after ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days after admission to ICU
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
90 days after admission to ICU
Hospital length of stay
Time Frame: 28 days after admission
Hospital length of stay/days alive and free of hospital by day 28
28 days after admission
Hospital length of stay
Time Frame: 90 days after admission
Hospital length of stay/days alive and free of hospital by day 90
90 days after admission
Free of organ support
Time Frame: 28 days after admission
Days alive and free of organ support (including PN free days) by day 28
28 days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 333874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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