Cardiac ArrestPhase 4HypothermiaNCT00827957
Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients
A Phase 4 study testing Internal Cooling and External Cooling in people with Cardiac Arrest, run by Singapore General Hospital at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Internal Cooling and External Cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesSingapore
- Study dates
- Oct 2008to Oct 2014
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hypotension despite fluid and/or vasopressor support
- Positive pregnancy test in women below 50 years
- Premorbid status bedbound and uncommunicative
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National Heart Centre Singapore
Singapore, 168752
Singapore General Hospital
Singapore, 169608
About this study
Official 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
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.
Read the 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.
- Conditions
- Cardiac Arrest
- Being tested
- Internal Cooling, External Cooling
- Keywords
- Hypothermia, Internal cooling, External cooling, Cardiac arrest
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal CoolingDevice
Also called Alsius Thermogard
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.
External CoolingDevice
Also called Arctic Sun
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Internal Cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to hospital discharge
Measured: 30 days post arrest
Secondary outcomes (1)
Neurological status of post-resuscitation patients
Measured: 1 year post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Centre Singapore
- Responsible party
- Sponsor
- Investigators
- Marcus EH Ong, MBBS, MPH, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827957
- Sponsor's protocol ID
- CIRB 2008/080/C
- Acronym
- Hypothermia
- Status last verified
- Feb 2017
- First submitted
- 21 Jan 2009
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24188226
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00827957
- Acronym / sponsor ID
- Hypothermia / CIRB 2008/080/C
- Conditions
- Cardiac Arrest
- Keywords
- Hypothermia, Internal cooling, External cooling, Cardiac arrest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National Heart Centre Singapore
- Study start
- Oct 2008
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Jan 2009 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Cooling | Active comparator | Device: External CoolingThe 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. |
| Internal Cooling | Active comparator | Device: Internal CoolingThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Hypotension despite fluid and/or vasopressor support
- Positive pregnancy test in women below 50 years
- Premorbid status bedbound and uncommunicative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal CoolingAlso: Alsius ThermogardThe 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 |
| External CoolingAlso: Arctic SunThe 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 |
Primary outcome
Survival to hospital discharge
Time frame: 30 days post arrest
1 secondary outcome
Neurological status of post-resuscitation patients
Time frame: 1 year post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Derived from this study: PubMed 24188226Ferreira 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.
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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.
Marcus EH Ong, MBBS, MPH principal investigator
Singapore General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Internal Cooling and External Cooling in people with Cardiac Arrest, run by Singapore General Hospital at 2 sites in Singapore.
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 4 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: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival to hospital discharge (time frame: 30 days post arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00827957, which also lists 1 linked publication.
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 10 Feb 2017.