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Evaluation of an Anti-Shivering Protocol Cardiac Arrest

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05264246
Enrollment
165
Registered
2022-03-03
Start date
2021-09-15
Completion date
2024-09-09
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

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.

Interventions

None listed

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
NMB usageJune 1, 2017 - May 31, 2021vecuronium or cisatracurium

Secondary

MeasureTime frameDescription
NMB usageJune 1, 2017 - May 31, 2021Proportion of patients that required any vecuronium boluses Number of vecuronium boluses administered Proportion of patients that required initiation of cisatracurium infusion
Patients discharged homeJune 1, 2017 - May 31, 2021Proportion of patients discharged home
Patients with a breakthrough fever (temperature > 38°C) in the first 72 hours of TTM initiationFirst 72 hours of TTM initiationProportion 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°CJune 1, 2017 - May 31, 2021number of patients at desired temperature range
Time to target temperature from initiation of TTMJune 1, 2017 - May 31, 2021time in minutes
ICU length of stayJune 1, 2017 - May 31, 2021number of days

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTamara Reiter, PharmD

Methodist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026