Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 2:09 PM
Study NCT ID:
NCT02470520
Status:
COMPLETED
Last Update Posted:
2016-05-17
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Essential Nutrients in Critically Ill Patients With Severe AKI Treated With and Without CRRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-16', 'studyFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum levels of essential nutrients', 'timeFrame': 'up to 6 days'}], 'secondaryOutcomes': [{'measure': 'levels of essential nutrients in filtrate', 'timeFrame': 'up to 6 days', 'description': 'concentrations of trace elements, vitamins and amino acids in filtrate in patients on CRRT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Kidney Failure']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI. In patients who are treated with continuous renal replacement therapy, we plan to evaluate whether there are any additional losses of nutrients into the filtrate.', 'detailedDescription': 'Background: Critically ill patients with acute kidney injury (AKI) have a high risk of dying, especially if renal replacement therapy (RRT) is needed. It remains uncertain whether essential trace elements, vitamins and amino acids are lost during RRT in sufficient amounts to result in clinically significant deficiencies. At present, nutrition guidelines for patients with AKI on RRT do not account for any potential losses of micronutrients across the filter.\n\nHypothesis:\n\nCritically ill patients with AKI have inadequate plasma nutrient levels. If continuous renal replacement therapy (CRRT) is required, there are additional losses of essential nutrients.\n\nAims:\n\nTo serially measure plasma levels of essential vitamins, trace elements and amino acids in critically ill patients with severe AKI and to evaluate whether there are any additional losses into the filtrate during CRRT\n\nObjectives:\n\nTo perform serial measurements of plasma levels of selenium, zinc, copper, iron, vitamins B1, B6, B12, C and D, folic acid and essential amino acids in all patients with severe AKI and to measure any losses of the same nutrients in the filtrate in a cohort of patients on CRRT for \\>24 hours.\n\nPatient population:\n\nlevel 3 critically ill adult patients with severe AKI\n\nStudy size:\n\n40 patients of whom 20 patients are treated with CRRT for \\>24 hours.\n\nStudy design:\n\nobservational non-interventional study in at least 2 large tertiary care centres in the United Kingdom\n\nOutcomes:\n\nPrimary outcome: difference in plasma concentrations of essential trace elements and vitamins between patients with and without CRRT.\n\nSecondary outcomes: a) concentrations of trace elements, vitamins and amino acids in filtrate in patients on CRRT; b) differences in filtrate losses between patients on CRRT ≤30ml/kg/hr versus \\>30ml/kg/hr.\n\nLaboratory measurements:\n\nMeasurement of baseline plasma Selenium, Zinc, Copper, iron, Vitamins B1, B6, B12, C and D, folic acid and essential amino acids levels and repeat serial measurement of the same panel of nutrients in all patients for up to 6 days with additional concomitant measurement of nutrient levels in filtrate in cohort of patients on CRRT. In addition, daily measurement of serum electrolytes, liver profile, serum albumin and c-reactive protein.\n\nData collection:\n\nRecording of the following potential confounders: type of nutrition, dose of CRRT, type of membrane.\n\nStatistics:\n\nDetermination of the change in plasma nutrient levels over 6 days, and between baseline and 24 - 144 hours after initiation of CRRT. The estimates will be used to inform the design of an intervention study exploring the value of nutrient supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients with severe acute kidney injury', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult patients in the Critical Care Unit with severe AKI\n\nExclusion Criteria:\n\n* pre-existing dialysis dependent renal failure\n* life expectancy \\<48 hours\n* need for total parenteral nutrition\n* need for supplementation with intravenous multivitamins or trace elements\n* Jehovah's witness\n* patients with haemoglobin \\<7g/dL (unless being transfused for clinical reasons)"}, 'identificationModule': {'nctId': 'NCT02470520', 'briefTitle': 'Essential Nutrients in Critically Ill Patients With Severe AKI Treated With and Without CRRT', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Observational Study Measuring Essential Nutrients in Critically Ill Patients With Severe Acute Kidney Injury Treated With and Without Continuous Haemofiltration', 'orgStudyIdInfo': {'id': 'RJ113/N062'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AKI without CRRT', 'description': 'Patients with AKI who are not treated with continuous renal replacement therapy'}, {'label': 'AKI with CRRT', 'description': 'Patients with AKI who are treated with continuous renal replacement therapy', 'interventionNames': ['Procedure: CRRT']}], 'interventions': [{'name': 'CRRT', 'type': 'PROCEDURE', 'description': 'continuous renal replacement therapy', 'armGroupLabels': ['AKI with CRRT']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}