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Sodium Bicarbonate in Cardiopulmonary Resuscitation (SB CAT)

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ClinicalTrials.gov Identifier: NCT01377337
Recruitment Status : Unknown
Verified November 2011 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2011
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Tracking Information
First Submitted Date  ICMJE June 16, 2011
First Posted Date  ICMJE June 21, 2011
Last Update Posted Date November 8, 2011
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2011)
Short-term survival [ Time Frame: at completion of CPR ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sodium Bicarbonate in Cardiopulmonary Resuscitation
Official Title  ICMJE Does the Early Use of Sodium Bicarbonate Improve Results of Cardiopulmonary Resuscitation Following Out-of-Hospital Cardiac Arrest - a Prospective, Controlled Clinical Trial
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.

Detailed Description

General: Prospective, randomized, double blinded, placebo-controlled clinical trial. Exception from Informed Consent, under the regulations for the conduction of research in emergency situations, has been approved by the Helsinki Committee of the Rambam Medical Center and by the Supreme Helsinki Committee of the Israeli Ministry of Health. Included will be adult patients who suffer an OHCA, who do not respond to basic CPR and to early defibrillation and in whom advanced CPR is initiated. 1st dose (1 mEq/Kg) of SB/placebo will be administered by Israeli Magen David Adom (MDA) advanced life support (ALS) teams immediately following the first IV epinephrine. SB/placebo vials or syringes will be masked and coded. Calculated sample size is 2130 patients. Study endpoints include only short-term outcome variables - rates of ROSC and of admission to the emergency room.

Expected results: Based on previous analysis we expect a 20% improved short-term outcome in the SB treated group. Sample size was calculated accordingly.

Importance: Around 2.2 million OHCA's are treated by EMS worldwide annually. Current ROSC rate is ca. 30%. A 20% better short-term outcome will result in over 130,000 additional patients regaining spontaneous circulation annually.

Probable implications to Medicine: The use of SB in CPR is controversial. Current International Guidelines for CPR present very reserved recommendations regarding SB use. Results of this study may have a direct impact on the Guidelines and on the conduction of CPR world-wide. Based on the results of this trial, a Phase II trial, researching the effects of early SB administration on long-term outcome (hospital discharge and final neurological outcome) may be warranted and conducted.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sudden Cardiac Arrest
Intervention  ICMJE Drug: sodium bicarbonate

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).

Study Arms  ICMJE
  • Active Comparator: Sodium bicarbonate
    1 mEq/kg sodium bicarbonate administered intravenously immediately following the administration of the first epinephrine dose during advanced CPR.
    Intervention: Drug: sodium bicarbonate
  • Placebo Comparator: 0.9% NaCl
    1 ml/kg of 0.9% NaCl (Blinded label)
    Intervention: Drug: sodium bicarbonate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 20, 2011)
2130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01377337
Other Study ID Numbers  ICMJE 0013-09-RMB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gad Bar-Joseph Rambam Health Care Campus
PRS Account Rambam Health Care Campus
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP