Fluid therapy to patients reciving therapeutic hypothermia after cardiac arrest

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: Trade Name: HyperHAES Product Name: HyperHAES Pharmaceutical Form: Intravenous infusion Trade Name: Ringer Acetat solution Product Name: Ringer Ac Pharmaceutical Form: Intravenous infusion CONDITION: 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. PRIMARY OUTCOME: 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. 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. 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. 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
Epistemonikos ID: 0a468a7fda0b16b7d623e22ee3bb9c77b02a0cd9
First added on: Aug 21, 2024