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Low Dialysate Temperature During SLED

Primary Purpose

Acute Kidney Injury, Intra-dialytic Hypotension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Changing dialysate temperature
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A

    Group B

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Effect on baseline body temperature
    Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED
    Effect on total ultrafiltration
    The total amount of fluid ordered to be removed will be compared with the amount actually removed
    Effect on Kt/V
    The dialysis dose will be monitored

    Full Information

    First Posted
    January 2, 2018
    Last Updated
    January 5, 2018
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03397992
    Brief Title
    Low Dialysate Temperature During SLED
    Official Title
    Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 16, 2017 (Actual)
    Primary Completion Date
    April 22, 2017 (Actual)
    Study Completion Date
    April 22, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury, Intra-dialytic Hypotension

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare Provider
    Masking Description
    Patients, primary providers, ICU nurses and primary nephrology team are blinded. The PI and the dialysis nurses are not.
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    Treatment with high dialysate temperature first followed by low dialysate temperature and alternating thereafter.
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Treatment with low dialysate temperature first followed by high dialysate temperature and alternating thereafter
    Intervention Type
    Other
    Intervention Name(s)
    Changing dialysate temperature
    Intervention Description
    Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)
    Primary Outcome Measure Information:
    Title
    Number of intradialytic hypotension episodes with different dialysate temperatures
    Description
    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.
    Time Frame
    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 Measure Information:
    Title
    Effect on baseline body temperature
    Description
    Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED
    Time Frame
    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
    Title
    Effect on total ultrafiltration
    Description
    The total amount of fluid ordered to be removed will be compared with the amount actually removed
    Time Frame
    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
    Title
    Effect on Kt/V
    Description
    The dialysis dose will be monitored
    Time Frame
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30394919
    Citation
    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.
    Results Reference
    derived

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