Evaluation of an Anti-Shivering Protocol Cardiac Arrest

• Sponsor: Methodist Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05264246
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 11.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest

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 Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluation of an Anti-Shivering Protocol for Targeted Temperature Management Following Cardiac Arrest
• Actual Study Start Date: Sep 15, 2021
• Anticipated Primary Completion Date: Sep 15, 2024
• Anticipated Study Completion Date: Sep 15, 2024

Outcome Measures

Primary Outcome Measures

1. NMB usage [June 1, 2017 - May 31, 2021]

   vecuronium or cisatracurium

Secondary Outcome Measures

1. 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

2. Patients discharged home [June 1, 2017 - May 31, 2021]

   Proportion of patients discharged home

3. 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

4. Proportion of patients cooled to 33°C versus 36°C [June 1, 2017 - May 31, 2021]

   number of patients at desired temperature range

5. Time to target temperature from initiation of TTM [June 1, 2017 - May 31, 2021]

   time in minutes

6. ICU length of stay [June 1, 2017 - May 31, 2021]

   number of days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75203

Sponsors and Collaborators

• Methodist Health System

Investigators

• Principal Investigator: Tamara Reiter, PharmD, Methodist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Methodist Health System
• ClinicalTrials.gov Identifier: NCT05264246
• Other Study ID Numbers: 042.PHA.2021.D
• First Posted: Mar 3, 2022
• Last Update Posted: Mar 3, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Arrest

Study Results

No Results Posted as of Mar 3, 2022