Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT03736005
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skeletal Muscle Wasting and Renal Dysfunction After Critical Illness Trauma - Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D002908', 'term': 'Chronic Disease'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Quadriceps muscle tissue, blood and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-13', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in estimated Glomerular Filtration Rate (eGFR) between creatinine- and cystatin C-based estimates.', 'timeFrame': 'At 7 days after ICU discharge.'}], 'secondaryOutcomes': [{'measure': 'Rectus Femoris muscle wasting', 'timeFrame': 'From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge. Time period up to and including 18 months from recruitment.', 'description': 'Change in cross sectional area of Rectus Femoris assessed via ultrasound'}, {'measure': 'Diagnosis of a negative Nitrogen Balance', 'timeFrame': 'From ICU admission (day 1 to 10) and 7 days after ICU discharge.', 'description': 'Serum and urinary urea measurements aggregated as net nitrogen balance.'}, {'measure': 'Respiratory muscle wasting', 'timeFrame': 'From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.', 'description': 'Change in cross sectional area of intercostal muscle, change in diaphragm thickness'}, {'measure': 'Loss of muscle quality', 'timeFrame': 'From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.', 'description': 'Change in Rectus femoris muscle echogenecity'}, {'measure': 'Loss of functional capacity', 'timeFrame': '7 days and 6 months after ICU discharge.', 'description': 'Change in Functional Independence Measure'}, {'measure': 'Diagnosis of Anxiety of Depression', 'timeFrame': '7 days and 6 months after ICU discharge.', 'description': 'Change in Hospital Anxiety and Depression Scale'}, {'measure': 'Diagnosis of Sarcopaenia', 'timeFrame': 'From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.', 'description': 'Assessed using bioelectrical impedance analysis, change in cross sectional area of abdominal skeletal muscle,'}, {'measure': 'Diagnosis of Intensive care unit acquired weakness', 'timeFrame': 'From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.', 'description': 'Assessed using MRC Sum score'}, {'measure': 'Diagnosis of Intensive care unit acquired weakness', 'timeFrame': 'From ICU admission (day 1 to 10) and 7 days and 6 months after ICU discharge.', 'description': 'Assessed using hand grip strength.'}, {'measure': 'Change in quality of life', 'timeFrame': 'pre-admission baseline then 7 days and 6 months after ICU discharge.', 'description': 'Change in Euroqol 5d 5L (European quality of life group, quality of life instrument version 5D5L)'}, {'measure': 'Change in walking capacity', 'timeFrame': '7 days and 6 months after ICU discharge.', 'description': 'Change in Six minute walk test'}, {'measure': 'Diagnosis of chronic kidney disease', 'timeFrame': '6 months after ICU discharge', 'description': 'Diagnosis using creatinine clearance, iohexol and serum creatinine derived eGFR'}, {'measure': 'Diagnosis of non-recovery of eGFR to baseline', 'timeFrame': 'From ICU admission (day 3 to 10) and 7 days after ICU discharge.', 'description': 'Diagnosis using creatinine clearance, iohexol and serum creatinine derived eGFR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Acute Kidney Injury', 'Muscle Loss', 'Major Trauma', 'Quality of Life', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '28614196', 'type': 'BACKGROUND', 'citation': 'Ravn B, Prowle JR, Martensson J, Martling CR, Bell M. Superiority of Serum Cystatin C Over Creatinine in Prediction of Long-Term Prognosis at Discharge From ICU. Crit Care Med. 2017 Sep;45(9):e932-e940. doi: 10.1097/CCM.0000000000002537.'}, {'pmid': '37256861', 'type': 'DERIVED', 'citation': 'Haines RW, Fowler AJ, Liang K, Pearse RM, Larsson AO, Puthucheary Z, Prowle JR. Comparison of Cystatin C and Creatinine in the Assessment of Measured Kidney Function during Critical Illness. Clin J Am Soc Nephrol. 2023 Aug 1;18(8):997-1005. doi: 10.2215/CJN.0000000000000203. Epub 2023 May 31.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine changes in kidney function during and after critical illness, comparing conventional creatinine based methods with the gold standard to accurately establish the presence of new or worsened chronic kidney disease. In addition, investigators will assess the confounding effect of muscle wasting on the conventional assessment of kidney function and investigate the information that measures of kidney function may contribute to the assessment of musculoskeletal health after critical illness.', 'detailedDescription': "More people than ever are surviving life-threatening illnesses such as major trauma. However, until now doctors and researchers have focused more on improving short term survival than on the serious, long-term complications experienced by survivors of critical illness. In response, the National Institute for Health and Care Excellence (NICE) and patient-clinician partnerships such as the James Lind Alliance, have now prioritised research into the diagnosis, follow-up and treatment of critical care survivors.\n\nDevelopment of chronic kidney disease and persistent muscle weakness are two commonly encountered complications which significantly impact long-term health and wellbeing after critical illness. Worsening of kidney function strongly predisposes to development of heart disease, premature death or need for long-term dialysis. Similarly, the muscle wasting experienced by almost all survivors of critical illness can result in persistent, life changing limitations to daily living, inability to work and decreased quality of life. Importantly, the human and economic consequences of critical illness may be particularly profound in major trauma victims who are often young and previously healthy. In this project, investigators will aim to simultaneously measure changes in kidney function and muscle mass after critical illness allowing researchers to understand how these processes interact in affecting longer-term patient outcomes.\n\nThe investigators will recruit 62 patients, 31 admitted to intensive care after major trauma and 31 admitted for other reasons. Complementary methods will be used to accurately monitor muscle mass and kidney function. Six months after discharge from hospital, patient's ability to manage their daily activities and quality of life will be assessed alongside measurements of muscle mass, strength and kidney function. The study will be performed at the Royal London Hospital, an internationally renowned centre for critical care and trauma research."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to critical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major trauma cohort: Patients ≥18y admitted to ICU and anticipated to be mechanically ventilated for ≥48 hours with a primary admission diagnosis of major trauma.\n* Non-trauma cohort: Patients ≥18y admitted to ICU and anticipated to be mechanically ventilated for ≥48 hours without a primary admission diagnosis of major trauma.\n\nExclusion Criteria:\n\n* Death or discharge from hospital considered highly likely by treating physician within 7 days of ICU admission.\n* Any of the following conditions: major traumatic brain injury (Abbreviated Injury Scale head injury score ≥ 5), spinal cord injury with paralysis, lower limb amputation, end stage renal disease or disseminated cancer, lack of independence with activities of daily living or non-ambulatory status prior to admission. (Rationale - exclusion of factors where type of injury or comorbid disease will overwhelming determine functional or renal outcomes.)'}, 'identificationModule': {'nctId': 'NCT03736005', 'acronym': 'KRATOS', 'briefTitle': 'Skeletal Muscle Wasting and Renal Dysfunction After Critical Illness Trauma - Outcomes Study', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'Skeletal Muscle Wasting and Renal Dysfunction in Patients After Critical Illness and Major Trauma - Outcomes Study', 'orgStudyIdInfo': {'id': 'KRATOSProtocolv1.2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General ICU admissions', 'description': 'Non- major trauma ICU admission Exposure to significant period of critical illness', 'interventionNames': ['Other: Exposure of significant critical illness']}, {'label': 'Major Trauma admissions', 'description': 'Exposure to Major Trauma Exposure to significant period of critical illness', 'interventionNames': ['Other: Exposure of significant critical illness']}], 'interventions': [{'name': 'Exposure of significant critical illness', 'type': 'OTHER', 'description': 'Exposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments.', 'armGroupLabels': ['General ICU admissions', 'Major Trauma admissions']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E11BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}