Sodium Bicarbonate in Cardiopulmonary Resuscitation (SB CAT)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2011 by Rambam Health Care Campus.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT01377337

First received: June 16, 2011

Last updated: November 6, 2011

Last verified: November 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Sudden Cardiac Arrest	Drug: sodium bicarbonate	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Does the Early Use of Sodium Bicarbonate Improve Results of Cardiopulmonary Resuscitation Following Out-of-Hospital Cardiac Arrest - a Prospective, Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: CPR Cardiac Arrest

Drug Information available for: Sodium bicarbonate

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

Short-term survival [ Time Frame: at completion of CPR ] [ Designated as safety issue: No ]
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


Estimated Enrollment:	2130
Study Start Date:	December 2011
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Sodium bicarbonate 1 mEq/kg sodium bicarbonate administered intravenously immediately following the administration of the first epinephrine dose during advanced CPR.	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).
Placebo Comparator: 0.9% NaCl 1 ml/kg of 0.9% NaCl (Blinded label)	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).

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377337

Contacts


Contact: Gad Bar-Joseph, Prof.	972-50-2062115	g_barjoseph@rambam.health.gov.il
Contact: Rachel Gil, RN	972-50-2064257	r_gil@rambam.health.gov.il

Locations


Israel
Rambam Medical Center	Not yet recruiting
Haifa, Israel, 31096
Contact: Gad Bar-Joseph, Prof. g_barjoseph@rambam.health.gov.il
Magen David Adom	Not yet recruiting
Tel Aviv, Israel
Contact: Zvi Figenberg, MD zvif@mdais.co.il

Sponsors and Collaborators

Rambam Health Care Campus

Investigators


Principal Investigator:	Gad Bar-Joseph	Rambam Health Care Campus

More Information

No publications provided


Responsible Party:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT01377337 History of Changes
Other Study ID Numbers:	0013-09-RMB
Study First Received:	June 16, 2011
Last Updated:	November 6, 2011
Health Authority:	Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:


cardiac arrest cardiopulmonary resuscitation (sodium) bicarbonate return of spontaneous circulation outcome

Additional relevant MeSH terms:


Heart Arrest Cardiovascular Diseases Heart Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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