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Low Dialysate Temperature During SLED

Not Applicable
Completed
Conditions
Acute Kidney Injury
Intra-dialytic Hypotension
Interventions
Other: Changing dialysate temperature
Registration Number
NCT03397992
Lead Sponsor
Washington University School of Medicine
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
38
Inclusion Criteria
  • 18 years of age or older, AKI stage 3 requiring RRT, maximum two pressers, initial temperature of 36°C or higher.
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Exclusion Criteria
  • Initial temperature less than 36°C, ESRD, three or more pressers, requirement of antihypertensive medications.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Group BChanging dialysate temperatureTreatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter
Group AChanging dialysate temperatureTreatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter.
Primary Outcome Measures
NameTimeMethod
Number of intradialytic hypotension episodes with different dialysate temperaturesParticipants 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

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.

Secondary Outcome Measures
NameTimeMethod
Effect on baseline body temperatureParticipants 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

Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED

Effect on total ultrafiltrationParticipants 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

The total amount of fluid ordered to be removed will be compared with the amount actually removed

Effect on Kt/VParticipants 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

The dialysis dose will be monitored

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