Low Dialysate Temperature During SLED

The Washington University

Status: Completed

Conditions: Acute Kidney Injury; Intra-dialytic Hypotension

Treatments: Other: Changing dialysate temperature

Study type: Interventional

Funder types: Other

Identifiers

NCT03397992

201612031

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Group A

Active Comparator group

Description:

Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter.

Treatment:

Other: Changing dialysate temperature

Group B

Active Comparator group

Description:

Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter

Treatment:

Other: Changing dialysate temperature