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Completed

NCT Number: NCT03397992

Low Dialysate Temperature During SLED

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intra-dialytic Hypotension Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Changing dialysate temperature

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Low Dialysate Temperature to Prevent Intradialytic Hypotension During SLED in AKI

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2018
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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