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Fluid therapy to patients reciving therapeutic hypothermia after cardiac arrest - CORE COOLING

Fluid therapy to patients reciving therapeutic hypothermia after cardiac arrest - CORE COOLING

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005111-24-NO
Enrollment
50
Registered
2005-11-04
Start date
2006-01-16
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

The study is carried out on patients at our Hospital, being treated with therapeutic hypothermia after cardiac arrest. The aim of the study is to tell if standard fluid therapy (RingerAC) leads to a different contain of oedema, compared to those pasiente reciving HyperHAES. We state the level of oedema both subcutaneous and intracerebral. We also study if these fluid therapies have a different effect concerning deaths, survivours etc.

Interventions

Trade Name: HyperHAES Product Name: HyperHAES Pharmaceutical Form: Intravenous infusion Trade Name: Ringer Acetat solution Product Name: Ringer Ac Pharmaceutical Form: Intravenous infusion

Sponsors

Dept. of Anaesthesia and Intensive Care, Haukeland University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients admitted to this trial have to been exposed to a cardiac arrest, being vitnessed by their family, bystanders etc. The patiens also have to recive advanced CRP within 15 min. after their heart stopped. Return of spontanous circulation has to be stated within 60 minutes after the event. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patiens suffering from severe life-threatening deseases like cancer com. met, etc. will be excluded. They who are younger than 18 years, or older than 80 years will also be excluded, as well those who have recived more than 2000 ml of intravenous fluid before admitted to our hospital. All other causes to the cardiac arrest than the cardial, like hypoxi, intoxocation ect, will be ruled out.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: Secondary objectives are to state the level of oedema in their brains, (using MRI) and level of oedema subcutaneous.(Wicks`method). We also register the total amount of days in the ICU, the length of the intrahospital stay ect, the rate of adverse effects like infections ect.;Primary end point(s): The primary end points are the number of deaths and survivours in the two groups. Furthermore will the cognitive score after 12 months, be classified as a primary end point.;Main Objective: The main objective is to study different effects on rate of death, and the patients need for help/ward afterwards. We also perform a cognitive score of all these patiens a year after their cardiac arrest.

Countries

Norway

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026