NCT00827957

Brief Summary

Controlled therapeutic hypothermia is a method of preserving neurological function post-resuscitation.It has been associated with improved functional recovery and reduced histological deficits in animal models of cardiac arrest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

6 years

First QC Date

January 21, 2009

Last Update Submit

February 9, 2017

Conditions

Cardiac Arrest

Keywords

HypothermiaInternal coolingExternal coolingCardiac arrest

Outcome Measures

Primary Outcomes (1)

  • Survival to hospital discharge

    30 days post arrest

Secondary Outcomes (1)

  • Neurological status of post-resuscitation patients

    1 year post discharge

Study Arms (2)

External Cooling

ACTIVE COMPARATOR

The gel-coated external cooling device consists of four water circulating gel coated energy transfer pads, and is placed on the patient's back, abdomen, and both thighs. Depending on the size used, the total surface area ranges between 0.60 and 0.77 m2. It is connected to an automatic thermostat controlling the temperature of the circulating water (4°C to 42°C) based on the patient's core temperature.

Device: External Cooling

Internal Cooling

ACTIVE COMPARATOR

The intravascular cooling system uses a single lumen (8.5 Fr,38 cm) central venous catheter inserted into the inferior vena cava via the left or right femoral vein. Normal saline is pumped through three balloons mounted on the catheter and returned to a central system in a closed loop. The saline flow within the balloons is in close contact with the patient's blood flow and serves as a heat exchange system. An automatic temperature control device adjusts the temperature of the circulating saline (4°C to 42°C) based on the patient's core temperature.

Device: Internal Cooling

Interventions

Internal CoolingDEVICE

The intravascular cooling system uses a single lumen (8.5 Fr,38 cm) central venous catheter inserted into the inferior vena cava via the left or right femoral vein. Normal saline is pumped through three balloons mounted on the catheter and returned to a central system in a closed loop. The saline flow within the balloons is in close contact with the patient's blood flow and serves as a heat exchange system. An automatic temperature control device adjusts the temperature of the circulating saline (4°C to 42°C) based on the patient's core temperature.

Also known as: Alsius Thermogard
Internal Cooling
External CoolingDEVICE

The gel-coated external cooling device consists of four water circulating gel coated energy transfer pads, and is placed on the patient's back, abdomen, and both thighs. Depending on the size used, the total surface area ranges between 0.60 and 0.77 m2. It is connected to an automatic thermostat controlling the temperature of the circulating water (4°C to 42°C) based on the patient's core temperature.

Also known as: Arctic Sun
External Cooling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min
  • Patients aged between 18 to 80 years.
  • Patients who are hemodynamically stable, with a systolic BP \> 90 mmHg with or without inotropic support.
  • Patients comatose or unresponsive post-resuscitation

You may not qualify if:

  • Hypotension despite fluid and/or vasopressor support
  • Positive pregnancy test in women below 50 years
  • Premorbid status bedbound and uncommunicative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Heart Centre Singapore

Singapore, 168752, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (1)

  • Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010.

    PMID: 24188226DERIVED

MeSH Terms

Conditions

Heart ArrestHypothermia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marcus EH Ong, MBBS, MPH

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 23, 2009

Study Start

October 1, 2008

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

SG(2)