Evaluation of an Anti-Shivering Protocol Cardiac Arrest

NCT ID: NCT05264246

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2024-09-09

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Diagnosis of cardiac arrest
* Initiation of TTM via Arctic SunĀ® 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara Reiter, PharmD

Role: PRINCIPAL_INVESTIGATOR

Methodist

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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042.PHA.2021.D

Identifier Type: -

Identifier Source: org_study_id

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