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Blood Gas Analysis and Buffering In Cardiac Arrest

NCT01362556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2014-06-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Gerhard Prause, Prof. Dr. · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362556 on ClinicalTrials.gov