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NCT Number: NCT03973814

Hypothermia Risk With Continuous Renal Replacement Therapy

The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during continuous renal replacement therapy as compared to the Prismaflo IIS blood warmer used for the PrismaFlex system.

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Key information

Conditions

Acute Kidney Injury Body Temperature Changes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypothermia Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

Blood warming devices during continuous renal replacement therapy (CRRT) have not been adequately tested.

The novel TherMax blood warmer for the newly introduced PrisMax System heats blood and replacement solutions via a dry heat plate system. In contrast, the PRISMAFLO IIS Blood Warmer for PRISMAFLEX System uses an electric heating sleeve on a standard CRRT filter set.

Data on adverse events (AE) during continuous renal replacement therapy (CRRT) has been studied and one of the most common AE was hypothermia, reported in 44% of all cases.

The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during CRRT as compared to the blood warmer used for the PrismaFlex system.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (18-100 years) critically ill patients treated with CRRT.

Exclusion criteria

  • Patients under 18 years of age. Non-RRT patients.

Treatment and study plan

Thermax Blood Warmer

Device

Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.

Primary outcomes

  1. Temperature, accuracy

    Time frame: 24 hours

    During use of Thermax; hourly difference between prescribed temperature-measured temperature; accuracy 0,1 Celsius

Secondary outcomes

  1. Temperature, differences

    Time frame: 12-18 hours (six hour warming period)

    Difference to 36.5 Celsius, std deviation, interquartile range: Prior to Thermax, during Thermax and after Thermax

  2. Historic comparator

    Time frame: 24 hours

    Using registry/PDMS data, how did the old blood warmer perform with regards to temperature

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Skane University Hospital

Registry information

Acronym: HR-CRRT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2019
Registry last updated
Dec 22, 2023

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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