Cardiopulmonary ArrestPhase 3SICARENCT02225561
SNPeCPR In Cardiac Arrest REsuscitation
A Phase 3 study testing pharmaco- mechanical optimization and mechanical optimization only in people with Cardiopulmonary Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic resuscitation survival after cardiac arrest remains low (1-8%) and has not changed significantly over the past five decades.It has recently been… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiopulmonary Arrest
- What is being tested?
- pharmaco- mechanical optimization and mechanical optimization only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2015to 2 Jan 2018
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with out of hospital cardiac arrest
- Age> 18 years and <75 years
- Initial Rhythm: Ventricular fibrillation or ventricular tachycardia or pulseless electrical activity
Who cannot join
- out of hospital cardiac arrest of non-cardiac origin:
- trauma
- anoxic, including drowning
- hemorrhage,
- overdose (drugs),
- drug,
Show all 14Show fewer
- electric
- Do Not Resuscitate Order,
- obvious signs of clinical death (decomposition, cadaveric rigidity, decapitation)
- recent sternotomy (<6 months or recent scar)
- Contraindications related to sodium nitroprusside
- Women of childbearing age (between 18 and 55 years)
- Other contra-indications will usually not known during resuscitation in case of presence of a relative rescue team must be searched: Hypothyroidism, Sulfuryl transferase deficiency (rhodanese Lang) currently recognized in patients with Leber optic atrophy, tobacco amblyopia or severe hepatic impairment.
- Obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SNPeCPR Pour la prIse en Charge Des Arrêts CaRdiaques Extrahospitaliers
Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic resuscitation survival after cardiac arrest remains low (1-8%) and has not changed significantly over the past five decades.It has recently been shown that the combination of different non-invasive therapies, cardiopulmonary resuscitation with mechanical CPR with automated compression / decompression and an impedance threshold device, can increase the rate of return of spontaneous circulation and short and long term survival after cardiac arrest.We propose to study a new cardiopulmonary resuscitation called SNPeCPR (Sodium nitroprusside enhanced cardiopulmonary resuscitation), which includes two components:a) a mechanical component: cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold deviceb) a pharmacological component: sodium nitroprusside, an effective arterial vasodilator that decrease vascular resistance, and improve flow in vital organs.Our hypothesis is that SNPeCPR should improve the return of spontaneous circulation rate during cardiac arrest.
Read the detailed description
- OBJECTIVES The objective of this study is to demonstrate the superiority of Sodium nitroprusside enhanced cardiopulmonary resuscitation (SNPeCPR) on optimized standard cardiopulmonary resuscitation. SNPeCPR includes two components:
- a mechanical component: cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold device
- a pharmacological component: sodium nitroprusside, an effective arterial vasodilator that decreasing vascular resistance, facilitates flow elevation in vital organs. 1.1. Main Objective : Assess the interests of the administration of sodium nitroprusside during enhanced cardiopulmonary resuscitation. 1.2. Secondary Objectives : To evaluate the effect of sodium nitroprusside on various parameters before and after the return of spontaneous circulation. 1.3. Outcome Measures : In this declaration, all the criterions measures before ROSC have been note as t=0 minute. For the elements were the timeframe is a variable, ICU and hospital discharge, they have been declare at 1 and 2 weeks respectively.
- NAME AND DESCRIPTION OF THE INVESTIGATIONAL DRUG Sodium nitroprusside (SNP) is a potent vasodilator that we will use in cardiac arrest to optimize vital organs perfusion. The purpose of CPR is to provide oxygenated blood to vital organs that are most susceptible to ischemic insult (brain and heart). Since the mechanical combination (cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold device) provides excellent perfusion pressure, the flow should be optimized pharmacological with vasodilation. The SNP reduces arterial vasoconstriction and enhances microcirculation. Furthermore, SNP significantly reduces vascular resistance and decreases cardiac ejection afterload. Therefore, SNPeCPR can significantly increase the flow of blood and optimize carotid and coronary flow.
- PROCEDURE During cardiac arrest resuscitation, patients will be included in the study after the investigator has verified the inclusion and non-inclusion criterion. A sealed box containing SNP or the placebo will then be open in the increasing numbers of randomization list. Whatever the allocated treatment (nitroprusside or Placebo [5% glucose solution]), cardiopulmonary resuscitation protocol will be realize as recommended by the 2010 European Resuscitation Council and described as follows:
- cardiopulmonary resuscitation will be performed continuously without posing for control pulse until the first defibrillation attempt. As soon as possible manual CPR will be replace by automated mechanical external chest compression (LUCAS® - Lund University Cardiopulmonary Assist System) and an impedance threshold device (ResQPOD®).
- placement of a peripheral intravenous (IV) or intraosseous (IO) line. This placement will be privileged to intubation,
- when the peripheral intravenous or intraosseous line is set, 1.96 mg sodium nitroprusside (SNP) / placebo will be injected, followed by injection of 10 ml saline for intravenous flush (t = 0 minutes).
- 1 mg of epinephrine will be injected at t = 2 minutes,
- an external electric shock (EEC) will be realized at t = 3 minutes when the electric heart type allows it (ventricular fibrillation or ventricular tachycardia),
- 0.98 mg sodium nitroprusside / placebo will be injected at t = 4 minutes, followed by an injection of 10 ml of saline for intravenous flush.
- 1 mg adrenaline will be injected at t = 7 minutes, the injection will be repeated every 5 minutes until return of spontaneous circulation or ending of the resuscitation decided by the emergency physician.
- an external electric shock (EEC) will be realized at t = 6 minutes when the electric heart type allows, then external shock will be repeated every 3 minutes until return of spontaneous circulation or ending of the resuscitation decided by the emergency physician. During that resuscitation the following parameters will be collected:
- The type of cardiac arrest (place of cardiac arrest [home, public place, stadium …], cardiac arrest before a witness or prompt rescue team, cardiac massage by the witness or prompt rescue team, durations between collapse and the start of resuscitation, non-specialized / specialized resuscitation, defibrillation shock by the witness or prompt rescue team), ETCO2, blood pressure and SpO2.
- the initial electrical rhythm (defined by ECG) by the mobile intensive care unit (MICI) and ECG 5 minutes after return of spontaneous circulation.
- arterial blood gas lactate
- troponin (24 hours after ROSC)
- liver function (24 hours after ROSC)
- creatinine (24 hours after ROSC)
- echocardiography (4 and 24 hours after ROSC)
- EXPECTED DURATION OF PARTICIPATION OF PEOPLE AND DESCRIPTION OF THE TIMING AND DURATION OF THE RESEARCH. Duration of intervention: 4 minutes Inclusion time: 30 months duration of participation (+ monitoring treatment): 6 months Total duration of the study: 3 years
- RANDOMIZATION Randomization will be realized by block and will be stratified by center. The boxes are numbered and contain drugs specified by the randomization arm. Randomization will be done by assigning at each inclusion a box taken in order of increasing numbers of the randomization list. The randomization list will be established under the responsibility of the clinical research unit.
- MONITORING COMMITTEE A monitoring committee will conduct an interim analysis after the inclusion of 50% and 75% of patients and will decide to stop or continue the study.
- Conditions
- Cardiopulmonary Arrest
- Being tested
- pharmaco- mechanical optimization, mechanical optimization only
- Keywords
- Cardiopulmonary resuscitation, Nitroprusside, Transthoracic, Impedances
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaco- mechanical optimizationProcedure or surgery
Getting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt.
As soon the peripheral intravenous or intraosseous line is set the intervention group will receive an injection of 2 mg of sodium nitroprusside. 4 minutes after the first injection, a second and last injection of 1 mg of sodium nitroprusside will be realized.- The preparation procedure of the sodium nitroprusside will be:
- Using a "pomping needle" and the provided syringe 4 ml of the solvent (Water for Injections, WFI) will be take.
- The 4 ml of WFI will be empty in the 50 mg vial of lyophilisate sodium nitroprusside to solubilize the product.
- Always with the needle and 20 ml syringe, the 4 ml of this solution (50 mg in 4 ml) will be collect.
mechanical optimization onlyProcedure or surgery
Getting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Pharmaco- mechanical optimization Receives: Procedure: pharmaco- mechanical optimization |
| Mechanical optimization only | Active comparator | Mechanical optimization only Receives: Procedure: mechanical optimization only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of return of spontaneous circulation (ROSC)
Rate of return of spontaneous circulation (ROSC) defined as a central pulse (carotid or femoral) palpable for more than 5 minutes
Measured: at 5 minutes
Secondary outcomes (11)
ETCO2
ETCO2 (before ROSC, 5 and 60 min after ROSC)
Measured: at 0, 5 and 60 minutes
Blood pressure
at 5 and 60 min after ROSC
Measured: at 5 and 60 min
ECG
ECG (before ROSC, 5 min after ROSC)
Measured: at 0, 5 and 60 minutes
SpO2
SpO2 (before ROSC, 5 and 60 min after ROSC)
Measured: at 0, 5 and 60 minutes
Arterial blood gases with lactate
arterial blood gases with lactate (before ROSC, 5 min, 1, 4 and 24 hours after ROSC)
Measured: at 0 and 5 minutes; 1, 4 and 24 hours
Troponin
troponin (24 hours after ROSC)
Measured: at 24 hours
Liver function
liver function (24 hours after ROSC)
Measured: at 24 hours
Creatinine
creatinine (24 hours after ROSC)
Measured: at 24 hours
Echocardiography
echocardiography (4 and 24 hours after ROSC)
Measured: at 4 and 24 hours
Survival
survival (1, 4 and 24 hours after ROSC, ICU and hospital discharge, 1 and 6 months)
Measured: 1, 4 and 24 hours, 1 week, 2 weeks, 1 and 6 months
Neurological score
neurological score (ICU and hospital discharge, 1 and 6 months)
Measured: 1 week, 2 weeks, 1 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start2 Jan 2015
- Primary completion2 Jul 2017
- Study completion2 Jan 2018
Why it stopped: Discontinuation of the experimental treatment being tested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ArrestStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick PLAISANCE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225561
- Sponsor's protocol ID
- P130946
- Other IDs
- 2014-002010-24, 2014
- Acronym
- SICARE
- Status last verified
- Jan 2020
- First submitted
- 25 Aug 2014
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schultz J, Segal N, Kolbeck J, Caldwell E, Thorsgard M, McKnite S, Aufderheide TP, Lurie KG, Yannopoulos D. Sodium nitroprusside enhanced cardiopulmonary resuscitation prevents post-resuscitation left ventricular dysfunction and improves 24-hour survival and neurological function in a porcine model of prolonged untreated ventricular fibrillation. Resuscitation. 2011 Dec;82 Suppl 2(0 2):S35-40. doi: 10.1016/S0300-9572(11)70149-6.
PubMed 22208176Schultz J, Segal N, Kolbeck J, McKnite S, Caldwell E, Yannopoulos D. Sodium nitroprusside enhanced cardiopulmonary resuscitation (SNPeCPR) improves vital organ perfusion pressures and carotid blood flow in a porcine model of cardiac arrest. Resuscitation. 2012 Mar;83(3):374-7. doi: 10.1016/j.resuscitation.2011.07.038. Epub 2011 Aug 22.
PubMed 21864483Schultz JC, Segal N, Caldwell E, Kolbeck J, McKnite S, Lebedoff N, Zviman M, Aufderheide TP, Yannopoulos D. Sodium nitroprusside-enhanced cardiopulmonary resuscitation improves resuscitation rates after prolonged untreated cardiac arrest in two porcine models. Crit Care Med. 2011 Dec;39(12):2705-10. doi: 10.1097/CCM.0b013e31822668ba.
PubMed 21725236Yannopoulos D, Matsuura T, Schultz J, Rudser K, Halperin HR, Lurie KG. Sodium nitroprusside enhanced cardiopulmonary resuscitation improves survival with good neurological function in a porcine model of prolonged cardiac arrest. Crit Care Med. 2011 Jun;39(6):1269-74. doi: 10.1097/CCM.0b013e31820ed8a6.
PubMed 21358401
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SNPeCPR Pour la prIse en Charge Des Arrêts CaRdiaques Extrahospitaliers
- ClinicalTrials.gov ID
- NCT02225561
- Acronym / sponsor ID
- SICARE / P130946
- Conditions
- Cardiopulmonary Arrest
- Keywords
- Cardiopulmonary resuscitation, Nitroprusside, Transthoracic, Impedances
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of the experimental treatment being tested
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 2 Jul 2017 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 26 Aug 2014 (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.
Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic resuscitation survival after cardiac arrest remains low (1-8%) and has not changed significantly over the past five decades.It has recently been shown that the combination of different non-invasive therapies, cardiopulmonary resuscitation with mechanical CPR with automated compression / decompression and an impedance threshold device, can increase the rate of return of spontaneous circulation and short and long term survival after cardiac arrest.We propose to study a new cardiopulmonary resuscitation called SNPeCPR (Sodium nitroprusside enhanced cardiopulmonary resuscitation), which includes two components:a) a mechanical component: cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold deviceb) a pharmacological component: sodium nitroprusside, an effective arterial vasodilator that decrease vascular resistance, and improve flow in vital organs.Our hypothesis is that SNPeCPR should improve the return of spontaneous circulation rate during cardiac arrest.
Detailed description
- OBJECTIVES The objective of this study is to demonstrate the superiority of Sodium nitroprusside enhanced cardiopulmonary resuscitation (SNPeCPR) on optimized standard cardiopulmonary resuscitation. SNPeCPR includes two components:
- a mechanical component: cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold device
- a pharmacological component: sodium nitroprusside, an effective arterial vasodilator that decreasing vascular resistance, facilitates flow elevation in vital organs. 1.1. Main Objective : Assess the interests of the administration of sodium nitroprusside during enhanced cardiopulmonary resuscitation. 1.2. Secondary Objectives : To evaluate the effect of sodium nitroprusside on various parameters before and after the return of spontaneous circulation. 1.3. Outcome Measures : In this declaration, all the criterions measures before ROSC have been note as t=0 minute. For the elements were the timeframe is a variable, ICU and hospital discharge, they have been declare at 1 and 2 weeks respectively.
- NAME AND DESCRIPTION OF THE INVESTIGATIONAL DRUG Sodium nitroprusside (SNP) is a potent vasodilator that we will use in cardiac arrest to optimize vital organs perfusion. The purpose of CPR is to provide oxygenated blood to vital organs that are most susceptible to ischemic insult (brain and heart). Since the mechanical combination (cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold device) provides excellent perfusion pressure, the flow should be optimized pharmacological with vasodilation. The SNP reduces arterial vasoconstriction and enhances microcirculation. Furthermore, SNP significantly reduces vascular resistance and decreases cardiac ejection afterload. Therefore, SNPeCPR can significantly increase the flow of blood and optimize carotid and coronary flow.
- PROCEDURE During cardiac arrest resuscitation, patients will be included in the study after the investigator has verified the inclusion and non-inclusion criterion. A sealed box containing SNP or the placebo will then be open in the increasing numbers of randomization list. Whatever the allocated treatment (nitroprusside or Placebo [5% glucose solution]), cardiopulmonary resuscitation protocol will be realize as recommended by the 2010 European Resuscitation Council and described as follows:
- cardiopulmonary resuscitation will be performed continuously without posing for control pulse until the first defibrillation attempt. As soon as possible manual CPR will be replace by automated mechanical external chest compression (LUCAS® - Lund University Cardiopulmonary Assist System) and an impedance threshold device (ResQPOD®).
- placement of a peripheral intravenous (IV) or intraosseous (IO) line. This placement will be privileged to intubation,
- when the peripheral intravenous or intraosseous line is set, 1.96 mg sodium nitroprusside (SNP) / placebo will be injected, followed by injection of 10 ml saline for intravenous flush (t = 0 minutes).
- 1 mg of epinephrine will be injected at t = 2 minutes,
- an external electric shock (EEC) will be realized at t = 3 minutes when the electric heart type allows it (ventricular fibrillation or ventricular tachycardia),
- 0.98 mg sodium nitroprusside / placebo will be injected at t = 4 minutes, followed by an injection of 10 ml of saline for intravenous flush.
- 1 mg adrenaline will be injected at t = 7 minutes, the injection will be repeated every 5 minutes until return of spontaneous circulation or ending of the resuscitation decided by the emergency physician.
- an external electric shock (EEC) will be realized at t = 6 minutes when the electric heart type allows, then external shock will be repeated every 3 minutes until return of spontaneous circulation or ending of the resuscitation decided by the emergency physician. During that resuscitation the following parameters will be collected:
- The type of cardiac arrest (place of cardiac arrest [home, public place, stadium …], cardiac arrest before a witness or prompt rescue team, cardiac massage by the witness or prompt rescue team, durations between collapse and the start of resuscitation, non-specialized / specialized resuscitation, defibrillation shock by the witness or prompt rescue team), ETCO2, blood pressure and SpO2.
- the initial electrical rhythm (defined by ECG) by the mobile intensive care unit (MICI) and ECG 5 minutes after return of spontaneous circulation.
- arterial blood gas lactate
- troponin (24 hours after ROSC)
- liver function (24 hours after ROSC)
- creatinine (24 hours after ROSC)
- echocardiography (4 and 24 hours after ROSC)
- EXPECTED DURATION OF PARTICIPATION OF PEOPLE AND DESCRIPTION OF THE TIMING AND DURATION OF THE RESEARCH. Duration of intervention: 4 minutes Inclusion time: 30 months duration of participation (+ monitoring treatment): 6 months Total duration of the study: 3 years
- RANDOMIZATION Randomization will be realized by block and will be stratified by center. The boxes are numbered and contain drugs specified by the randomization arm. Randomization will be done by assigning at each inclusion a box taken in order of increasing numbers of the randomization list. The randomization list will be established under the responsibility of the clinical research unit.
- MONITORING COMMITTEE A monitoring committee will conduct an interim analysis after the inclusion of 50% and 75% of patients and will decide to stop or continue the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Procedure: pharmaco- mechanical optimizationPharmaco- mechanical optimization |
| Mechanical optimization only | Active comparator | Procedure: mechanical optimization onlyMechanical optimization only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with out of hospital cardiac arrest
- Age> 18 years and <75 years
- Initial Rhythm: Ventricular fibrillation or ventricular tachycardia or pulseless electrical activity
Key exclusion criteria (14 listed)
- out of hospital cardiac arrest of non-cardiac origin:
- Do Not Resuscitate Order,
- obvious signs of clinical death (decomposition, cadaveric rigidity, decapitation)
- recent sternotomy (<6 months or recent scar)
- Contraindications related to sodium nitroprusside
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 |
|---|---|---|
| pharmaco- mechanical optimizationGetting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt. As soon the peripheral intravenous or intraosseous line is set the intervention group will receive an injection of 2 mg of sodium nitroprusside. 4 minutes after the first injection, a second and last injection of 1 mg of sodium nitroprusside will be realized.- The preparation procedure of the sodium nitroprusside will be: * Using a "pomping needle" and the provided syringe 4 ml of the solvent (Water for Injections, WFI) will be take. * The 4 ml of WFI will be empty in the 50 mg vial of lyophilisate sodium nitroprusside to solubilize the product. * Always with the needle and 20 ml syringe, the 4 ml of this solution (50 mg in 4 ml) will be collect. | Procedure or surgery | Intervention arm |
| mechanical optimization onlyGetting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt. | Procedure or surgery | Mechanical optimization only |
Primary outcome
Rate of return of spontaneous circulation (ROSC)
Time frame: at 5 minutes
Rate of return of spontaneous circulation (ROSC) defined as a central pulse (carotid or femoral) palpable for more than 5 minutes
11 secondary outcomes
ETCO2
Time frame: at 0, 5 and 60 minutes
Blood pressure
Time frame: at 5 and 60 min
ECG
Time frame: at 0, 5 and 60 minutes
SpO2
Time frame: at 0, 5 and 60 minutes
Arterial blood gases with lactate
Time frame: at 0 and 5 minutes; 1, 4 and 24 hours
Troponin
Time frame: at 24 hours
Liver function
Time frame: at 24 hours
Creatinine
Time frame: at 24 hours
Echocardiography
Time frame: at 4 and 24 hours
Survival
Time frame: 1, 4 and 24 hours, 1 week, 2 weeks, 1 and 6 months
Neurological score
Time frame: 1 week, 2 weeks, 1 and 6 months
Results and safety
The study was stopped early (reason given: Discontinuation of the experimental treatment being tested). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Background: PubMed 22208176Schultz J, Segal N, Kolbeck J, Caldwell E, Thorsgard M, McKnite S, Aufderheide TP, Lurie KG, Yannopoulos D. Sodium nitroprusside enhanced cardiopulmonary resuscitation prevents post-resuscitation left ventricular dysfunction and improves 24-hour survival and neurological function in a porcine model of prolonged untreated ventricular fibrillation. Resuscitation. 2011 Dec;82 Suppl 2(0 2):S35-40. doi: 10.1016/S0300-9572(11)70149-6.
- Background: PubMed 21864483Schultz J, Segal N, Kolbeck J, McKnite S, Caldwell E, Yannopoulos D. Sodium nitroprusside enhanced cardiopulmonary resuscitation (SNPeCPR) improves vital organ perfusion pressures and carotid blood flow in a porcine model of cardiac arrest. Resuscitation. 2012 Mar;83(3):374-7. doi: 10.1016/j.resuscitation.2011.07.038. Epub 2011 Aug 22.
- Background: PubMed 21725236Schultz JC, Segal N, Caldwell E, Kolbeck J, McKnite S, Lebedoff N, Zviman M, Aufderheide TP, Yannopoulos D. Sodium nitroprusside-enhanced cardiopulmonary resuscitation improves resuscitation rates after prolonged untreated cardiac arrest in two porcine models. Crit Care Med. 2011 Dec;39(12):2705-10. doi: 10.1097/CCM.0b013e31822668ba.
- Background: PubMed 21358401Yannopoulos D, Matsuura T, Schultz J, Rudser K, Halperin HR, Lurie KG. Sodium nitroprusside enhanced cardiopulmonary resuscitation improves survival with good neurological function in a porcine model of prolonged cardiac arrest. Crit Care Med. 2011 Jun;39(6):1269-74. doi: 10.1097/CCM.0b013e31820ed8a6.
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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.
Patrick PLAISANCE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pharmaco- mechanical optimization and mechanical optimization only in people with Cardiopulmonary Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 14 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: stopped early, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Discontinuation of the experimental treatment being tested). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of return of spontaneous circulation (ROSC) (time frame: at 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225561, which also lists 4 linked publications.
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 10 Jan 2020.