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NCT Number: NCT00827957

Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients

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.

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Key information

Conditions

Cardiac Arrest Body Temperature Changes Cardiovascular Diseases Heart Arrest Heart Diseases Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Heart Centre Singapore, Singapore

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About this study

Three randomized clinical studies have been reported showing improved neurological outcome and reduced mortality in post-resuscitation patients treated with hypothermia compared to controls. Of the various methods of inducing hypothermia, internal cooling using an endovascular catheter and external cooling using gel pads with a water based circulating system have shown the most promise. There have not been any studies looking at outcomes between the two methods of cooling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Internal Cooling

Device

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.

Other names: Alsius Thermogard

External Cooling

Device

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.

Other names: Arctic Sun

Primary outcomes

  1. Survival to hospital discharge

    Time frame: 30 days post arrest

Secondary outcomes

  1. Neurological status of post-resuscitation patients

    Time frame: 1 year post discharge

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • National Heart Centre Singapore

Registry information

Official study title

A Phased Prospective Clinical Study Comparing Controlled Therapeutic Hypothermia Post Resuscitation After Cardiac Arrest Using External and Internal Cooling to Standard Intensive Care Unit Therapy

Acronym: Hypothermia

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2009
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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