Low Dialysate Temperature During SLED

Acute Kidney Injury Clinical Trial

Official title:

Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397992
• Other study ID #: 201612031
• Status: Completed
• Phase: N/A
• First received: January 2, 2018
• Last updated: January 5, 2018
• Start date: January 16, 2017
• Est. completion date: April 22, 2017

Study information

• Verified date: January 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 22, 2017
• Est. primary completion date: April 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hypotension
• Intra-dialytic Hypotension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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