Low Dialysate Temperature During SLED

Study Overview
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Brief Summary
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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.

Official Title
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Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI

Conditions
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Acute Kidney Injury, Intra-dialytic Hypotension

Intervention / Treatment
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* Other: Changing dialysate temperature


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter. | Other: Changing dialysate temperature<br>* Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)<br>|
| Active Comparator: Group B<br>Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter | Other: Changing dialysate temperature<br>* Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)<br>|

What is the study measuring?
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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 |