Cardiac Arrest With Successful Resuscitation | Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest
Cardiac Arrest With Successful Resuscitation research study
What is the primary objective of this study?
Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers are in use, together with analgesia and sedation, during the cooling process in many centers to prevent shivering. Since neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolong ICU stay. So economical use seems to be reasonable. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, post hypoxic seizures might remain undetected. Aim of this study is to investigate if a continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoid the counter regulation to achieve the target temperature as soon as possible in mild hypothermic therapy after cardiac arrest. A single center (university hospital) study. Randomized, double blinded, double dummy study design. Eligible are all adult patients after successful resuscitation due to cardiac arrest of presumed cardiac origin. All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin will be included. Patients <18 years, cardiac arrest >6 hours before admittance at the hospital, patients with known or clinically apparent pregnancy, patients who reach our hospital with a body temperature below 35°C, patients with known allergic reactions against rocuronium, patients with a history of myasthenia gravis, patients with obvious intoxication, wards of the state/prisoners and patients with known epileptic disease will be excluded. Primary outcome: Shivering episodes will be scored with the Shivering Assessment Scale. Secondary outcome: Total doses of rocuronium, time to target core temperature of 33°C, dissipated energy and total energy needed during the cooling period will be compared between the two groups. Changes in basal metabolism and depth of relaxation will be ascertained. Furthermore, serum levels of midazolam, fentanyl, rocuronium and stress hormones will be measured. Train-of-four will be performed to assess the depth of relaxation. Sedation will be monitored via bispectral index; measurement of metabolic activity will be evaluated using indirect calorimetry. Additionally, EEG will be performed to detect epileptiform activities. Blood will be drawn to measure levels of midazolam, fentanyl and rocuronium.
Who is eligible to participate?
Inclusion Criteria: - all patients receiving mild therapeutic hypothermia after cardiac arrest - cardiac arrest due to cardiopulmonary origin Exclusion Criteria: - patients younger than 18 years - traumatic cardiac arrest - cardiac arrest due to exsanguination, strangulation, smoke inhalation, drug overdose, electrocution, hanging or drowning - known or clinically apparent pregnancy - no treatment with mild therapeutic hypothermia because of an AND order - terminal illness - a body core temperature below 35°C at hospital admission - known allergic reaction against rocuronium - history of myasthenia gravis - obvious intoxication - ward of the state or prisoner - known epileptic disease - cardiac arrest >6 hours prior to hospital admission
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Cardiac Arrest With Successful Resuscitation
Skeletal Muscle Relaxant Overdose
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:rocuroniumcontinuous application of rocuronium 0,25mg/kg/h (blinded), in case of shivering episode bolus sodium-chloride (blinded)
Other:placebocontinuous infusion of sodium-chloride (blinded), in case of shivering episode application of rocuronium 0,25mg/kg (blinded)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
RocuroniumContinuous infusion of rocuronium with 0,25mg/kg (blinded) for 29 hours after initiation of mild therapeutic hypothermia
PlaceboContinuous infusion of sodium-chloride (placebo) and rocuronium bolus (0,25mg/kg)in case of shivering episode (blinded)
Start Date: November 2010
Completed Date: April 2015
Phase: Phase 3
Primary Outcome: Number of shivering episodes
Secondary Outcome: Elapsed time to target temperature
Study sponsors, principal investigator, and references
Principal Investigator: Heidrun Losert, MD
Lead Sponsor: Medical University of Vienna