Hypothermia Risk With Continuous Renal Replacement Therapy

NCT03973814 | Completed FDA Device

• 1 other identifier: BxIIRgrant
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury; Hypothermia

Keywords

continuous renal replacement therapy

Outcome Measures

Primary Outcomes (1)

• Temperature, accuracy

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

  24 hours

Secondary Outcomes (2)

• Temperature, differences

  12-18 hours (six hour warming period)

• Historic comparator

  24 hours

Study Arms (3)

Prior to Thermax Warming

ACTIVE COMPARATOR

Baseline temperature

Device: Thermax Blood Warmer

During warming

ACTIVE COMPARATOR

Temperature during Thermax warming

Device: Thermax Blood Warmer

Post warming

ACTIVE COMPARATOR

Temperature after cessation of Thermax warming

Device: Thermax Blood Warmer

Interventions

Thermax Blood Warmer DEVICE

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

During warming; Post warming; Prior to Thermax Warming

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Skane University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Acute Kidney Injury; Hypothermia

Condition Hierarchy (Ancestors)

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

Study Officials

• Max Bell, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Marcus Broman, MD, PhD

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator

Model Details: The investigators will assess body temperature before-, during- and after Thermax blood warming treatment. Patients are essentially their own controls. Moreover, we will use historic data on the previous blood warmer for the Prismaflex device to assess temperature changes.

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 4, 2019
• Study Start: August 1, 2022
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Six months after study completion
• Access Criteria: Data access will be reviewed by the PI:s and research group.

Locations

SE (1)