Acute Kidney Injury, Intra-dialytic Hypotension
Conditions
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.
Interventions
OTHERChanging dialysate temperature
Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients, primary providers, ICU nurses and primary nephrology team are blinded. The PI and the dialysis nurses are not.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed