NCT01362556

Blood Gas Analysis and Buffering In Cardiac Arrest

Blood Gas Analysis and Buffering In Cardiac Arrest - A Multicenter, Prospective, Randomised, Double Blind Prehospital Trial to Evaluate the Impact of Early Blood-gas-analysis Targeted Buffer Therapy on ROSC After OOHCA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrest

Interventions

Type	Name	Description
DRUG	Sodium bicarbonate	Administration of a calculated amount of sodium bicarbonate 8% \[SB\] after arterial blood gas measurement according to Base Excess \[BE\] and Body weight \[kg\]. Formula: SB \[ml\] = -BE \* kg \* 0.1
DRUG	Sodium Chloride	Administration of a calculated amount of sodium chloride 0.9% \[SC\] after arterial blood gas measurement according to Base Excess \[BE\] and Body weight \[kg\]. Formula: SC \[ml\] = -BE \* kg \* 0.1

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2011-05-30
• Last updated: 2014-06-03

Locations

6 sites across 1 country: Austria