NCT01292148

Brief Summary

The purpose of this study is to determine that the measurements of rectal and bladder temperature are correctly consistent with core temperature by using the pulmonary artery catheter during therapeutic hypothermia; rapid cooling, maintenance, and slow rewarming phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

February 7, 2011

Last Update Submit

July 17, 2015

Conditions

Cardiac Arrest

Keywords

resuscitation, hypothermia

Outcome Measures

Primary Outcomes (1)

  • Difference of core temperature between rectum, bladder, esophagus and pulmonary artery

    During 24 hour

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Post cardiac arrest care with therapeutic hypothermia

You may qualify if:

  • Out of cardiac arrest patient who is 18 years old.
  • Mean arterial pressure must be over 65 mmHg after return of spontaneous circulation.
  • Family consent to this study.

You may not qualify if:

  • In hospital arrest.
  • Arrest due to trauma
  • Arrest due to intracranial hemorrhage.
  • Below 30 degree at initial core temperature.
  • Pregnancy.
  • Family do not agree with our study.
  • Active bleeding patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Boramae Hospital

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Heart ArrestHypothermia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shin JongHwan

    Seoul National University Boramae Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seoul National University

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 9, 2011

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

KR(1)