NCT01362556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 3, 2014

Status Verified

June 1, 2014

Enrollment Period

2.8 years

First QC Date

April 27, 2011

Last Update Submit

June 2, 2014

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Rate of return of spontaneous circulation (ROSC)

    Within five hours from start of resuscitation.

Secondary Outcomes (2)

  • Survival to discharge after cardiac arrest

    participants will be followed for the duration of hospital stay, an expected average of 5 weeks

  • Survival after one year of hospital discharge

    One year after event

Study Arms (2)

Sodium Chloride

PLACEBO COMPARATOR

Group receiving sodium chloride 0.9% after arterial blood gas analysis in cardiac arrest.

Drug: Sodium Chloride

Sodium Bicarbonate

ACTIVE COMPARATOR

Group receiving targeted sodium bicarbonate 8% therapy after arterial blood gas analysis in cardiac arrest.

Drug: Sodium bicarbonate

Interventions

Sodium bicarbonateDRUG

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

Sodium Bicarbonate
Sodium ChlorideDRUG

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

Sodium Chloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • women of childbearing age
  • traumatic cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Landeskrankenhaus Klagenfurt

Klagenfurt, Carinthia, 9020, Austria

Location

Landesklinikum Wiener Neustadt

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Landeskrankenhaus Bruck / Mur

Bruck / Mur, Styria, 8600, Austria

Location

LKH Graz West

Graz, Styria, 8020, Austria

Location

Medical University Graz

Graz, Styria, 8036, Austria

Location

AKH Linz

Linz, Upper Austria, 4021, Austria

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Sodium BicarbonateSodium Chloride

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Gerhard Prause, Prof. Dr.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

April 27, 2011

First Posted

May 30, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

June 3, 2014

Record last verified: 2014-06

Locations

AU(6)