Gastrointestinal DysfunctionGUTPHOSNCT06376461
Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients
An observational study of Gastrointestinal Dysfunction, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Dysfunction
- What is being tested?
- Data collection
- How many people
- 92 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jul 2024to 26 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients admitted to the ICU within in the recruitment period will be recruited to the trial.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent
About this study
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.
- Conditions
- Gastrointestinal Dysfunction
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day outcome
28 day all cause mortality
Measured: 28 days after ICU admission
90 day outcome
90 day all cause mortality
Measured: 90 days after ICU admission
Secondary outcomes (5)
ICU length of stay
ICU length of stay/days alive and free of ICU by day 28
Measured: 28 days after admission to ICU
ICU length of stay
ICU length of stay/days alive and free of ICU by day 90
Measured: 90 days after admission to ICU
Hospital length of stay
Hospital length of stay/days alive and free of hospital by day 28
Measured: 28 days after admission
Hospital length of stay
Hospital length of stay/days alive and free of hospital by day 90
Measured: 90 days after admission
Free of organ support
Days alive and free of organ support (including PN free days) by day 28
Measured: 28 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start26 Jul 2024
- Primary completion31 Mar 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376461
- Sponsor's protocol ID
- 333874
- Acronym
- GUTPHOS
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06376461
- Acronym / sponsor ID
- GUTPHOS / 333874
- Conditions
- Gastrointestinal Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the ICU within in the recruitment period will be recruited to the trial.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionSites 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 | Other | – |
Primary outcome
28 day outcome
Time frame: 28 days after ICU admission
28 day all cause mortality
90 day outcome
Time frame: 90 days after ICU admission
90 day all cause mortality
5 secondary outcomes
ICU length of stay
Time frame: 28 days after admission to ICU
ICU length of stay
Time frame: 90 days after admission to ICU
Hospital length of stay
Time frame: 28 days after admission
Hospital length of stay
Time frame: 90 days after admission
Free of organ support
Time frame: 28 days after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Dysfunction, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day outcome (time frame: 28 days after ICU admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.