Low Dialysate Temperature During SLED
Primary Purpose
Acute Kidney Injury, Intra-dialytic Hypotension
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Changing dialysate temperature
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older, AKI stage 3 requiring RRT, maximum two pressers, initial temperature of 36°C or higher.
Exclusion Criteria:
- Initial temperature less than 36°C, ESRD, three or more pressers, requirement of antihypertensive medications.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter.
Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter
Outcomes
Primary Outcome Measures
Number of intradialytic hypotension episodes with different dialysate temperatures
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.
Secondary Outcome Measures
Effect on baseline body temperature
Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED
Effect on total ultrafiltration
The total amount of fluid ordered to be removed will be compared with the amount actually removed
Effect on Kt/V
The dialysis dose will be monitored
Full Information
NCT ID
NCT03397992
First Posted
January 2, 2018
Last Updated
January 5, 2018
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03397992
Brief Title
Low Dialysate Temperature During SLED
Official Title
Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
April 22, 2017 (Actual)
Study Completion Date
April 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Methods: 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Intra-dialytic Hypotension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Masking Description
Patients, primary providers, ICU nurses and primary nephrology team are blinded. The PI and the dialysis nurses are not.
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter
Intervention Type
Other
Intervention Name(s)
Changing dialysate temperature
Intervention Description
Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)
Primary Outcome Measure Information:
Title
Number of intradialytic hypotension episodes with different dialysate temperatures
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.
Time Frame
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
Secondary Outcome Measure Information:
Title
Effect on baseline body temperature
Description
Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED
Time Frame
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
Title
Effect on total ultrafiltration
Description
The total amount of fluid ordered to be removed will be compared with the amount actually removed
Time Frame
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
Title
Effect on Kt/V
Description
The dialysis dose will be monitored
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older, AKI stage 3 requiring RRT, maximum two pressers, initial temperature of 36°C or higher.
Exclusion Criteria:
Initial temperature less than 36°C, ESRD, three or more pressers, requirement of antihypertensive medications.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30394919
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.
Results Reference
derived
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Low Dialysate Temperature During SLED
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