Sudden Cardiac ArrestPhase 4SB CATNCT01377337
Sodium Bicarbonate in Cardiopulmonary Resuscitation
A Phase 4 study testing sodium bicarbonate in people with Sudden Cardiac Arrest, run by Rambam Health Care Campus at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sudden Cardiac Arrest
- What is being tested?
- sodium bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,130 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2011to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rambam Medical Center
Haifa, 31096
Gad Bar-Joseph, Prof., g_barjoseph@rambam.health.gov.il
Magen David Adom
Tel Aviv
Zvi Figenberg, MD, zvif@mdais.co.il
About this study
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
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.
Read the 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.
- Conditions
- Sudden Cardiac Arrest
- Being tested
- sodium bicarbonate
- Keywords
- cardiac arrest, cardiopulmonary resuscitation, (sodium) bicarbonate, return of spontaneous circulation, outcome
- Medical subject headings
- Death, Sudden, Cardiac, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Active comparator | 1 mEq/kg sodium bicarbonate administered intravenously immediately following the administration of the first epinephrine dose during advanced CPR. Receives: Drug: sodium bicarbonate |
| 0.9% NaCl | Placebo comparator | 1 ml/kg of 0.9% NaCl (Blinded label) Receives: Drug: sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at completion of CPR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gad Bar-Joseph, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377337
- Sponsor's protocol ID
- 0013-09-RMB
- Acronym
- SB CAT
- Status last verified
- Nov 2011
- First submitted
- 16 Jun 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01377337
- Acronym / sponsor ID
- SB CAT / 0013-09-RMB
- Conditions
- Sudden Cardiac Arrest
- Keywords
- cardiac arrest, cardiopulmonary resuscitation, (sodium) bicarbonate, return of spontaneous circulation, outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,130 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Active comparator | Drug: sodium bicarbonate1 mEq/kg sodium bicarbonate administered intravenously immediately following the administration of the first epinephrine dose during advanced CPR. |
| 0.9% NaCl | Placebo comparator | Drug: sodium bicarbonate1 ml/kg of 0.9% NaCl (Blinded label) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium bicarbonate1 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). | Drug | 0.9% NaCl, Sodium bicarbonate |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gad Bar-Joseph principal investigator
Rambam Health Care Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium bicarbonate in people with Sudden Cardiac Arrest, run by Rambam Health Care Campus at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gad Bar-Joseph, Prof. (972-50-2062115, g_barjoseph@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term survival (time frame: at completion of CPR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.