Low Dialysate Temperature During SLED

NCT03397992 | Completed

• 1 other identifier: 201612031
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury; Intra-dialytic Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Other: Changing dialysate temperature

Group B

ACTIVE COMPARATOR

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

Other: Changing dialysate temperature

Interventions

Changing dialysate temperature OTHER

Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older, AKI stage 3 requiring RRT, maximum two pressers, initial temperature of 36°C or higher.

You may not qualify if:

• Initial temperature less than 36°C, ESRD, three or more pressers, requirement of antihypertensive medications.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Publications (1)

• 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.

  PMID: 30394919 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients, primary providers, ICU nurses and primary nephrology team are blinded. The PI and the dialysis nurses are not.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 12, 2018
• Study Start: January 16, 2017
• Primary Completion: April 22, 2017
• Study Completion: April 22, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share