Early post-resuscitation survival outcomes in patients receiving norepinephrine versus epinephrine for post-resuscitation shock in a non-trauma emergency department: a parallel-group, open-label, feasibility randomized controlled trial
- Conditions
- post cardiac arrest patient who has post resuscitation shock within 1 hour after ROSCpost cardiac arrest, post resuscitation shock, norepinephrine, epinephrine
- Registration Number
- TCTR20220418001
- Lead Sponsor
- Emergency department, Siriraj hospital, Mahidol university
- Brief Summary
Twenty-five patients achieved target BP according to the protocol before reaching the termination criteria. No withdrawal patients from this study. The NE group required a statistical significantly lower dose of vasopressor compared to the EPI group. The lower dose required to achieve the target MAP in the NE group significantly implies better efficacy of NE in post-resuscitation shock.Mortality rate did not significantly different between both groups. No significant adverse event between two group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
We include adult patients 18 years or above who meeting all the criteria:
1.Non-traumatic cardiac arrest (one of the followings)
1.1Out-of-hospital cardiac arrest (OHCA) - defined as pulselessness prior to arrival at the ED
1.2 Emergency department cardiac arrest (EDCA) - defined as the sudden loss of pulse in the emergency department detected by medical personnel
2.ROSC after cardiopulmonary resuscitation (CPR) - defined as return of palpable pulse or measurable blood pressure by medical personnel
3.Post-resuscitation shock within 1 hour after ROSC - defined as mean arterial pressure (MAP) less than 65 mmHg or systolic blood pressure (SBP) less than 90 mmHg by non-invasive blood pressure (NIBP) monitoring or arterial blood pressure (ABP) monitoring
Patients will be excluded if they have one of these following terms:
1.The cause of cardiac arrest is ST-elevation myocardial infarction (STEMI) or STEMI-equivalent myocardial infarction.
In this study, we define as patients with history compatible with ischemic chest pain plus an electrocardiogram (ECG) before or after cardiac arrest that meets criteria of STEMI, or atypical ECG presentations that should prompt a primary percutaneous coronary intervention (PCI) strategy, according to 2017 European Society of Cardiology guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. These patients will be excluded for the reason that they would likely have cardiogenic shock, in which NE is preferred to EPI.
2.The diagnosis of cardiogenic shock is strongly suspected by the treating physicians or diagnosed by a consultant cardiologist.
3.The cause of cardiac arrest is anaphylaxis.
4.Patients with Do-Not-Resuscitate (DNR) order
5.Patients or legal representatives refuse vasopressors.
6.Pregnancy
7.Extracorporeal cardiopulmonary resuscitation (E-CPR) initiated before ROSC
8.Metastatic cancer or cancer patients who are currently receiving palliative treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The feasibility of the protocol 28 days after intervention Recruitment rate more than 8 patients per month and other feasibility outcome
- Secondary Outcome Measures
Name Time Method death and re-arrest within 3 hours within 3 hours of intervention clinician's diagnosis,28-day mortality 28 days after intervention clinician's diagnosis,refractory shock rate within 3 hours ofintervention clinician's diagnosis,significant supraventricular and ventricular arrhythmias within 3 hours of intervention clinician's diagnosis,6 hour after intervention outcome within 6 hours of intervention clinician's diagnosis