Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT06376461
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2024-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28 day outcome', 'timeFrame': '28 days after ICU admission', 'description': '28 day all cause mortality'}, {'measure': '90 day outcome', 'timeFrame': '90 days after ICU admission', 'description': '90 day all cause mortality'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': '28 days after admission to ICU', 'description': 'ICU length of stay/days alive and free of ICU by day 28'}, {'measure': 'ICU length of stay', 'timeFrame': '90 days after admission to ICU', 'description': 'ICU length of stay/days alive and free of ICU by day 90'}, {'measure': 'Hospital length of stay', 'timeFrame': '28 days after admission', 'description': 'Hospital length of stay/days alive and free of hospital by day 28'}, {'measure': 'Hospital length of stay', 'timeFrame': '90 days after admission', 'description': 'Hospital length of stay/days alive and free of hospital by day 90'}, {'measure': 'Free of organ support', 'timeFrame': '28 days after admission', 'description': 'Days alive and free of organ support (including PN free days) by day 28'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Dysfunction']}, 'descriptionModule': {'briefSummary': "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.\n\nPart 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to the ICU within in the recruitment period will be recruited to the trial.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to ICU during the study period (the patients already in the ICU at the time the study starts will not be included);\n* Age ≥18 years;\n* In participating centres in part B, serum Pi should be measured daily.\n\nExclusion Criteria:\n\n* Age \\<18 years;\n* Patients with restrictions of care such as "no intubation" or "no RRT" on ICU admission and patients admitted for treatment as organ donors;\n* Continuous chronic home ventilation for neuromuscular disease;\n* Declined participation or informed consent (if the local ethics committee requests the latter for this non-interventional study);\n* Readmission to ICU during the study period'}, 'identificationModule': {'nctId': 'NCT06376461', 'acronym': 'GUTPHOS', 'briefTitle': 'Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals of North Midlands NHS Trust'}, 'officialTitle': 'Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients', 'orgStudyIdInfo': {'id': '333874'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'University Hospitals of North Midlands NHS Trust', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals of North Midlands NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}