Evaluation of an Anti-Shivering Protocol Cardiac Arrest

Terminated

• Conditions: Cardiac Arrest

• Registration Number: NCT05264246
• Lead Sponsor: Methodist Health System

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-03
• Status Verified: 2024-09
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-09
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 165

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NMB usage	June 1, 2017 - May 31, 2021	vecuronium or cisatracurium

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States