Low Dialysate Temperature During SLED
- Conditions
- Acute Kidney InjuryIntra-dialytic Hypotension
- Interventions
- Other: Changing dialysate temperature
- Registration Number
- NCT03397992
- Lead Sponsor
- Washington University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 18 years of age or older, AKI stage 3 requiring RRT, maximum two pressers, initial temperature of 36°C or higher.
- Initial temperature less than 36°C, ESRD, three or more pressers, requirement of antihypertensive medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group B Changing dialysate temperature Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter Group A Changing dialysate temperature Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter.
- Primary Outcome Measures
Name Time Method Number of intradialytic hypotension episodes with different dialysate temperatures 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 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
Name Time Method Effect on baseline body temperature 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 Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED
Effect on total ultrafiltration 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 The total amount of fluid ordered to be removed will be compared with the amount actually removed
Effect on Kt/V 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 The dialysis dose will be monitored