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NCT05264246 Clinical Trial

Evaluation of an Anti-Shivering Protocol Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:
Evaluation of an Anti-Shivering Protocol for Targeted Temperature Management Following Cardiac Arrest

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05264246
Other study ID # 042.PHA.2021.D
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 15, 2021
Est. completion date September 15, 2024

Study information
Verified date February 2022
Source Methodist Health System
Contact Crystee Cooper, DHEd
Phone 214-947-1280
Email clinicalresearch@mhd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This will be a single center, retrospective, before-and-after, chart review of all patients undergoing TTM between June 1, 2017 and May 31, 2021 at MDMC. Initiation of the new TTM protocol occurred on April 22, 2019.

Description:

This will be a single center, retrospective, before-and-after, chart review of all patients undergoing TTM between June 1, 2017 and May 31, 2021 at MDMC. Initiation of the new TTM protocol occurred on April 22, 2019. To allow for an adequate washout period, patients who were initiated on TTM before April 22, 2019 will be in the "before" group and patients initiated on TTM on or after June 1, 2019 will be in the "after" group. Patients will be identified based on electronic medical records search of order sets utilized in TTM and confirmed with manual chart review. Statistical analysis will be performed as detailed below.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date September 15, 2024
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years - Diagnosis of cardiac arrest - Initiation of TTM via Arctic Sun® device Exclusion Criteria: - Initiation of TTM > 12 hours after cardiac arrest - Receiving NMBs for an indication other than TTM - Early termination of TTM (less than 24 hours)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary NMB usage vecuronium or cisatracurium June 1, 2017 - May 31, 2021
Secondary NMB usage Proportion of patients that required any vecuronium boluses
Number of vecuronium boluses administered
Proportion of patients that required initiation of cisatracurium infusion		 June 1, 2017 - May 31, 2021
Secondary Patients discharged home Proportion of patients discharged home June 1, 2017 - May 31, 2021
Secondary Patients with a breakthrough fever (temperature > 38°C) in the first 72 hours of TTM initiation Proportion of patients with a breakthrough fever (temperature > 38°C) in the first 72 hours of TTM initiation First 72 hours of TTM initiation
Secondary Proportion of patients cooled to 33°C versus 36°C number of patients at desired temperature range June 1, 2017 - May 31, 2021
Secondary Time to target temperature from initiation of TTM time in minutes June 1, 2017 - May 31, 2021
Secondary ICU length of stay number of days June 1, 2017 - May 31, 2021
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