Evaluation of an Anti-Shivering Protocol Cardiac Arrest

March 19, 2026 updated by: Methodist Health System

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

We plan to conduct the retrospective chart review of all patients identified during the study period (from June 1, 2017 to May 31, 2021) that meet the inclusion and exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NMB usage
Time Frame: June 1, 2017 - May 31, 2021
vecuronium or cisatracurium
June 1, 2017 - May 31, 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NMB usage
Time Frame: 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
June 1, 2017 - May 31, 2021
Patients discharged home
Time Frame: June 1, 2017 - May 31, 2021
Proportion of patients discharged home
June 1, 2017 - May 31, 2021
Patients with a breakthrough fever (temperature > 38°C) in the first 72 hours of TTM initiation
Time Frame: 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
Proportion of patients cooled to 33°C versus 36°C
Time Frame: June 1, 2017 - May 31, 2021
number of patients at desired temperature range
June 1, 2017 - May 31, 2021
Time to target temperature from initiation of TTM
Time Frame: June 1, 2017 - May 31, 2021
time in minutes
June 1, 2017 - May 31, 2021
ICU length of stay
Time Frame: June 1, 2017 - May 31, 2021
number of days
June 1, 2017 - May 31, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Tamara Reiter, PharmD, Methodist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

September 9, 2024

Study Completion (Actual)

September 9, 2024

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 042.PHA.2021.D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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