drugset / Trial / NCT01377337

Sodium Bicarbonate in Cardiopulmonary Resuscitation

NCT01377337

Phase 4 Unknown 2130 enrolled Rambam Health Care Campus
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Out-of-hospital cardiac arrests (OHCA) account for over 60% of deaths from coronary artery disease. The annual incidence of OHCA treated by Emergency Medical Systems (EMS) is 41-89 per 100,000 population. Outcome of OHCA and cardiopulmonary resuscitation (CPR) is very poor: Less than 1/3 of the victims regain spontaneous circulation (ROSC), 40-60% of those achieving ROSC suffer significant neurological disability due to brain hypoxia and only 1.7-6.4% are discharged from the hospital. In order to minimize hypoxia time, the primary goal of CPR is to achieve return of spontaneous circulation (ROSC) as fast as possible. Metabolic (lactic) acidosis develops rapidly during CA and is considered detrimental to CPR outcome. Sodium bicarbonate (SB), a generic, commonly used acid buffer, was subjected only to a single, small, prospective controlled trial that found a trend towards improved outcome in prolonged OHCA and CPR. Another study indicated that EMS's that used SB early and often during CPR had significantly higher ROSC rates and better long-term outcome compared with EMS's that used SB more seldom and administered it late in the course of CPR. Aim of the Study: To determine whether early administration of SB during OHCA and CPR improves short-term CPR outcome.

Timeline

Start
2011-12
Primary completion
2013-12
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator sodium bicarbonate Diagnostic / imaging agent 1 unknown Intravenous

Indications