An interventional study of Changing dialysate temperature in Acute Kidney Injury and Intra-dialytic Hypotension, sponsored by Washington University School of Medicine. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-12.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter.
Other: Changing dialysate temperature
Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter
Other: Changing dialysate temperature
Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)
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.
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
Effect on baseline body temperature
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
Effect on total ultrafiltration
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
Effect on Kt/V
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
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine