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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00827957

Acronym

Hypothermia

Enrollment

Registered

2009-01-23

Start date

2008-10-31

Completion date

2014-10-31

Last updated

2017-02-10

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

Conditions

Cardiac Arrest

Keywords

Hypothermia, Internal cooling, External cooling, Cardiac arrest

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.

Detailed description

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.

Interventions

DEVICEInternal Cooling

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.

DEVICEExternal Cooling

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min 2. Patients aged between 18 to 80 years. 3. Patients who are hemodynamically stable, with a systolic BP \> 90 mmHg with or without inotropic support. 4. Patients comatose or unresponsive post-resuscitation

Exclusion criteria

1. Hypotension despite fluid and/or vasopressor support 2. Positive pregnancy test in women below 50 years 3. Premorbid status bedbound and uncommunicative

Design outcomes

Primary

Measure	Time frame
Survival to hospital discharge	30 days post arrest

Secondary

Measure	Time frame
Neurological status of post-resuscitation patients	1 year post discharge

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026