NCT05264246

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2024

Completed
Last Updated

March 23, 2026

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

February 3, 2022

Last Update Submit

March 19, 2026

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • NMB usage

    vecuronium or cisatracurium

    June 1, 2017 - May 31, 2021

Secondary Outcomes (6)

  • NMB usage

    June 1, 2017 - May 31, 2021

  • 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

    First 72 hours of TTM initiation

  • Proportion of patients cooled to 33°C versus 36°C

    June 1, 2017 - May 31, 2021

  • Time to target temperature from initiation of TTM

    June 1, 2017 - May 31, 2021

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age \> 18 years
  • Diagnosis of cardiac arrest
  • Initiation of TTM via Arctic Sun® device

You may not qualify if:

  • Initiation of TTM \> 12 hours after cardiac arrest
  • Receiving NMBs for an indication other than TTM
  • Early termination of TTM (less than 24 hours)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Tamara Reiter, PharmD

    Methodist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

March 3, 2022

Study Start

September 15, 2021

Primary Completion

September 9, 2024

Study Completion

September 9, 2024

Last Updated

March 23, 2026

Record last verified: 2024-09

Locations

US(1)