Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2026-02-04 @ 3:03 AM
Study NCT ID:
NCT03397992
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2018-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dialysate Temperature During SLED
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Patients, primary providers, ICU nurses and primary nephrology team are blinded. The PI and the dialysis nurses are not.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-01-05', 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of intradialytic hypotension episodes with different dialysate temperatures', 'timeFrame': 'Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality', 'description': 'Hypothesis is that low dialysate temperature will decrease the number of hypotensive episodes during SLED treatment, hypotensive episodes are defined as drop in SBP ≥ 20 mm Hg or MAP ≥ 10 mm Hg, decrease in ultrafiltration rate, increase or start of vasoactive agents or termination of treatment because of hypotension.'}], 'secondaryOutcomes': [{'measure': 'Effect on baseline body temperature', 'timeFrame': 'Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality', 'description': 'Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED'}, {'measure': 'Effect on total ultrafiltration', 'timeFrame': 'Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality', 'description': 'The total amount of fluid ordered to be removed will be compared with the amount actually removed'}, {'measure': 'Effect on Kt/V', 'timeFrame': 'Participants who are enrolled are monitored during SLED treatment which can run from 8 to 14 hours for maximum of 8 treatments or till participant is switched to a different dialysis modality', 'description': 'The dialysis dose will be monitored'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'Intra-dialytic Hypotension']}, 'referencesModule': {'references': [{'pmid': '30394919', 'type': 'DERIVED', 'citation': 'Edrees FY, Katari S, Baty JD, Vijayan A. A Pilot Study Evaluating the Effect of Cooler Dialysate Temperature on Hemodynamic Stability During Prolonged Intermittent Renal Replacement Therapy in Acute Kidney Injury. Crit Care Med. 2019 Feb;47(2):e74-e80. doi: 10.1097/CCM.0000000000003508.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: This study is evaluating the hemodynamic effects of lowering the dialysate temperature in acute kidney injury (AKI) patients submitted to sustained low efficiency dialysis (SLED) in a single large center.\n\nMethods: Participants will be randomly assigned to two treatment groups. One group will be started treatment with low temperature (set point 5 on the machine which is around 35°C) for one treatment and then alternate between high and low temperatures for a maximum of 8 treatments. The other group will be started with high temperature (set point 9 on the machine which is around 37°C) for the first treatment then alternate between high and low temperatures for a maximum of 8 treatments. Each participants will need at least two treatments, one with each temperature to be included in the analysis. The investigators will be looking for the number of events during a SLED treatment. Events will be defined as drop in systolic blood pressure ≥ 20 mmHg or drop in mean arterial pressure (MAP) of ≥10 mmHg, requirement of resuscitation with IVF after initiation of SLED, initiation or increase requirement of vasoactive drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older, AKI stage 3 requiring RRT, maximum two pressers, initial temperature of 36°C or higher.\n\nExclusion Criteria:\n\n* Initial temperature less than 36°C, ESRD, three or more pressers, requirement of antihypertensive medications.'}, 'identificationModule': {'nctId': 'NCT03397992', 'briefTitle': 'Low Dialysate Temperature During SLED', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI', 'orgStudyIdInfo': {'id': '201612031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter.', 'interventionNames': ['Other: Changing dialysate temperature']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter', 'interventionNames': ['Other: Changing dialysate temperature']}], 'interventions': [{'name': 'Changing dialysate temperature', 'type': 'OTHER', 'description': 'Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)', 'armGroupLabels': ['Group A', 'Group B']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fahad Edrees', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}