Low Dialysate Temperature During SLED

Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Intra-dialytic Hypotension
• Intervention / Treatment: Other: Changing dialysate temperature

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Treatment with high dialysate temperature first followed by low 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)
Active Comparator: Group B; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on baseline body temperature	Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED	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	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	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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

General Publications

• Edrees FY, Katari S, Baty JD, Vijayan A. A Pilot Study Evaluating the Effect of Cooler Dialysate Temperature on Hemodynamic Stability During Prolonged Intermittent Renal Replacement Therapy in Acute Kidney Injury. Crit Care Med. 2019 Feb;47(2):e74-e80. doi: 10.1097/CCM.0000000000003508.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2017
• Primary Completion (Actual): April 22, 2017
• Study Completion (Actual): April 22, 2017

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Hypotension; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 201612031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No