Blood Gas Analysis and Buffering In Cardiac Arrest

Not Applicable

Completed

• Conditions: Cardiac Arrest
• Interventions: Drug: Sodium Chloride; Drug: Sodium bicarbonate

• Registration Number: NCT01362556
• Lead Sponsor: Medical University of Graz

Brief Summary

The debate over the administration of sodium bicarbonate in cardiac arrest has been going on for several decades, swinging like a pendulum from "first-line drug" to "not indicated" to the recent guidelines advocating "a small bolus under special conditions (metabolic acidosis, intoxication, long-term resuscitation)". A targeted, blood-gas controlled application under optimised ventilation conditions has not yet been evaluated prehospitally. Our preliminary studies have shown that an arterial puncture/line as well as measurement of blood gases is feasible in preclinical conditions. This multicentre trial including 5 centres and 10 physician-staffed emergency systems is designed to compare, in a prospective randomised controlled study, the effect of a calculated dosage of sodium bicarbonate based on the patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and on the secondary survival of cardiac arrest patients. The null hypothesis is that there is no or negative impact on survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-30
• Primary Completion: 2013-12
• Status Verified: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• prehospitally started cardiopulmonary resuscitation (CPR)
• advanced cardiac life support provided
• age >18 years
• arterial pH < 7,2
• arterial BE < -12
• arterial pCO2 15-75 mmHg
• arterial pO2 >35 mmHg

Exclusion Criteria

• women of childbearing age
• traumatic cardiac arrest

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride	Sodium Chloride	Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest.
Sodium Bicarbonate	Sodium bicarbonate	Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest.

Primary Outcome Measures

Name	Time	Method
Rate of return of spontaneous circulation (ROSC)	Within five hours from start of resuscitation.

Secondary Outcome Measures

Name	Time	Method
Survival to discharge after cardiac arrest	participants will be followed for the duration of hospital stay, an expected average of 5 weeks	Discharge from hospital
Survival after one year of hospital discharge	One year after event

Trial Locations

Locations (6)

LKH Graz West; 🇦🇹 Graz, Styria, Austria

Landeskrankenhaus Klagenfurt; 🇦🇹 Klagenfurt, Carinthia, Austria

Landesklinikum Wiener Neustadt; 🇦🇹 Wiener Neustadt, Lower Austria, Austria

Landeskrankenhaus Bruck / Mur; 🇦🇹 Bruck / Mur, Styria, Austria

Medical University Graz; 🇦🇹 Graz, Styria, Austria

AKH Linz; 🇦🇹 Linz, Upper Austria, Austria