Cardiac ArrestNCT05264246
Evaluation of an Anti-Shivering Protocol Cardiac Arrest
An observational study of Cardiac Arrest, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 9 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years
- Diagnosis of cardiac arrest
- Initiation of TTM via Arctic Sun® device
Who cannot join
- Initiation of TTM > 12 hours after cardiac arrest
- Receiving NMBs for an indication other than TTM
- Early termination of TTM (less than 24 hours)
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrest
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
NMB usage
vecuronium or cisatracurium
Measured: June 1, 2017 - May 31, 2021
Secondary outcomes (6)
NMB usage
Proportion of patients that required any vecuronium boluses
Number of vecuronium boluses administered
Proportion of patients that required initiation of cisatracurium infusion
Measured: June 1, 2017 - May 31, 2021
Patients discharged home
Proportion of patients discharged home
Measured: June 1, 2017 - May 31, 2021
Patients with a breakthrough fever (temperature > 38°C) in the first 72 hours of TTM initiation
Proportion of patients with a breakthrough fever (temperature > 38°C) in the first 72 hours of TTM initiation
Measured: First 72 hours of TTM initiation
Proportion of patients cooled to 33°C versus 36°C
number of patients at desired temperature range
Measured: June 1, 2017 - May 31, 2021
Time to target temperature from initiation of TTM
time in minutes
Measured: June 1, 2017 - May 31, 2021
ICU length of stay
number of days
Measured: June 1, 2017 - May 31, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start15 Sep 2021
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Why it stopped: PI requested to close the study. No study activity since 2021 and no intent to publish results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara Reiter, PharmD, Principal investigator, Methodist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264246
- Sponsor's protocol ID
- 042.PHA.2021.D
- Status last verified
- Sep 2024
- First submitted
- 3 Feb 2022
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Anti-Shivering Protocol for Targeted Temperature Management Following Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05264246
- Acronym / sponsor ID
- 042.PHA.2021.D
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI requested to close the study. No study activity since 2021 and no intent to publish results.
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age > 18 years
- Diagnosis of cardiac arrest
- Initiation of TTM via Arctic Sun® device
Key exclusion criteria (3 listed)
- Initiation of TTM > 12 hours after cardiac arrest
- Receiving NMBs for an indication other than TTM
- Early termination of TTM (less than 24 hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NMB usage
Time frame: June 1, 2017 - May 31, 2021
vecuronium or cisatracurium
6 secondary outcomes
NMB usage
Time frame: June 1, 2017 - May 31, 2021
Patients discharged home
Time frame: 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 cooled to 33°C versus 36°C
Time frame: June 1, 2017 - May 31, 2021
Time to target temperature from initiation of TTM
Time frame: June 1, 2017 - May 31, 2021
ICU length of stay
Time frame: June 1, 2017 - May 31, 2021
Results and safety
The study was stopped early (reason given: PI requested to close the study. No study activity since 2021 and no intent to publish results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Reiter, PharmD principal investigator
Methodist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI requested to close the study. No study activity since 2021 and no intent to publish results.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NMB usage (time frame: June 1, 2017 - May 31, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.