Overview

Sodium Bicarbonate in Cardiopulmonary Resuscitation

Status:
Unknown status
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Rambam Health Care Campus
Criteria
Inclusion Criteria:

- patients who suffer Out of hospital, non-traumatic cardiac arrest

- patients who do not respond to the initial resuscitation efforts (including basic CPR,
defibrillation (when indicated) and other appropriate ACLS measures)

- patients in whom a vascular access (either an IV line or an intraosseous needle) has
been obtained

- patients who have reached the "drugs" step in the ACLS algorithm.

Exclusion Criteria:

- Patients with known terminal illness

- Patients with a Do Not Resuscitate (or similar) order

- Cardiac arrest due to trauma, drug overdose or known intracranial disease

- Age less than 18 years

- Known pregnancy

- Patients in whom 30 minutes or more have passed from collapse to initiation of CPR

- If collapse time is unknown - patients with obvious death marks

- Patients with no vascular access (either an IV line or an intraosseous needle)