NCT01377337

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,130

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2011

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

June 16, 2011

Last Update Submit

November 6, 2011

Conditions

Sudden Cardiac Arrest

Keywords

cardiac arrestcardiopulmonary resuscitation(sodium) bicarbonatereturn of spontaneous circulationoutcome

Outcome Measures

Primary Outcomes (1)

  • Short-term survival

    proportion of patients who achieve return of spontaneous circulation (ROSC) and proportion of patients admitted alive (not requiring CPR) to the hospital's emergency room

    at completion of CPR

Study Arms (2)

Sodium bicarbonate

ACTIVE COMPARATOR

1 mEq/kg sodium bicarbonate administered intravenously immediately following the administration of the first epinephrine dose during advanced CPR.

Drug: sodium bicarbonate

0.9% NaCl

PLACEBO COMPARATOR

1 ml/kg of 0.9% NaCl (Blinded label)

Drug: sodium bicarbonate

Interventions

sodium bicarbonateDRUG

1 mEq/kg sodium bicarbonate administered intravenously immediately following the administration of the first epinephrine dose during advanced CPR. Dose may be repeated every 5-10 minutes up to 3 doses. Note: The Placebo Arm receives 1 ml/Kg of 0.9% NaCl (in a blinded fashion).

0.9% NaClSodium bicarbonate

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rambam Medical Center

Haifa, 31096, Israel

Location

Magen David Adom

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Death, Sudden, CardiacHeart Arrest

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Gad Bar-Joseph

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gad Bar-Joseph, Prof.

CONTACT

972-50-2062115g_barjoseph@rambam.health.gov.il

Rachel Gil, RN

CONTACT

972-50-2064257r_gil@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 21, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

IL(2)