We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Low Dialysate Temperature During SLED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03397992
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Acute Kidney Injury Intra-dialytic Hypotension Other: Changing dialysate temperature

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Patients, primary providers, ICU nurses and primary nephrology team are blinded. The PI and the dialysis nurses are not.
Primary Purpose: Prevention
Official Title: Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI
Actual Study Start Date : January 16, 2017
Primary Completion Date : April 22, 2017
Study Completion Date : April 22, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Number of intradialytic hypotension episodes with different dialysate temperatures [ 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 ]
    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 :
  1. Effect on baseline body temperature [ 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 ]
    Change of body temperature during and at end of SLED treatment from baseline temperature measured before starting SLED

  2. Effect on total ultrafiltration [ 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 ]
    The total amount of fluid ordered to be removed will be compared with the amount actually removed

  3. Effect on Kt/V [ 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 ]
    The dialysis dose will be monitored


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
More Information

Responsible Party: Fahad Edrees, Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03397992     History of Changes
Other Study ID Numbers: 201612031
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acute Kidney Injury
Hypotension
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Dialysis Solutions
Pharmaceutical Solutions