NCT03397992

Low Dialysate Temperature During SLED

Completed NA Last updated 12 January 2018

What this trial tests

NA trial testing Changing dialysate temperature in Acute Kidney Injury in 38 participants. Completed in 22 April 2017.

Timeline

16 January 2017

Primary endpoint
22 April 2017

22 April 2017

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	38
Start date	16 January 2017
Primary completion	22 April 2017
Estimated completion	22 April 2017

Drugs / interventions tested

• Changing dialysate temperature

Conditions studied

• Acute Kidney Injury — all drugs for Acute Kidney Injury →
• Intra-dialytic Hypotension — all drugs for Intra-dialytic Hypotension →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Acute Kidney Injury or Intra-dialytic Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An update review of intradialytic hypotension: concept, risk factors, clinical implications and management.
   Kanbay M, Ertuglu LA, Afsar B, Ozdogan E, et al · · 2020 · cited 143× · PMID 33391741 · DOI 10.1093/ckj/sfaa078