Cardiogenic ShockPhase 3SHOCK-NORDOBNCT03340779
Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock
A Phase 3 study testing Norepinephrine in people with Cardiogenic Shock, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Cardiogenic shock is a frequent cause of admission and death in the intensive care unit. Mortality is about 50%. Once the etiologic treatment has been done, for instance coronary revascularization, management of the shock state is the cornerstone of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2018to 1 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cardiogenic shock (ischemic, rythmic, valvular) defined : by cardiac index (CI) < 2,2 L/min/m² or CI < 2,5 L/min/m² under vasopressor/inotropic treatment and organ hypoperfusion signs : mottles, capillary refill time , urine output < 0,5 mL/kg/hour during at least one hour ou renal replacement therapy, consciouness impairment, pulmonary oedema, hyperlactatemia (> 2 mmoL/L)
- Mean arterial pressure > 65 mmHg under norepinephrine treatment
- Patients with social coverage
- Poisonings with cardiotoxicants
- Patient with intra-aortic ballon pump, extracorporeal life support
- Patient under guardianship
Who cannot join
- < 18 years old
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Nancy-Brabois
Vandœuvre-lès-Nancy, 54500
Thomas Auchet, MD, 033383157022, t.auchet@chru-nancy.fr
About this study
Official title: Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock : a Randomised, Opened, Cross-over Study. Heart SHOCK-NORDOB Study
Cardiogenic shock is a frequent cause of admission and death in the intensive care unit.
Mortality is about 50%. Once the etiologic treatment has been done, for instance coronary revascularization, management of the shock state is the cornerstone of the treatment. Norepinephrine is the first-line vasopressor therapy because of its minor effect on heart rhythm. Morever norepinephrine is a inotrope. In a previous study, we demonstrated that increasing the norepinephrine dose increases cardiac index, cardiac power index, SVO2 and tissue perfusion without acceleration of heart rate. Nevertheless, dobutamine remains the first-line inotropic treatment. Dobutamine has a positive chronotropic effect that might cause higher myocardial oxygen consumption. As a result, combination of vasopressor / inotrope is still controversial.
Read more
The aim of this study was to compare hemodynamics and metabolics effects of 2 treatments strategies (norepinephrine dose increasing or addition of dobutamine) in patients with cardiogenic shock and optimised blood pressure level (MAP≥65 mmHg) under norepinephrine treatment.
The secondary objectives were :
- To evaluate the efficacy of the treatments on micro- and macrocirculation parameters
- To evaluate the tolerance of the treatments
- To evaluate the dose and the admistration's kinetics of the treatments
- Conditions
- Cardiogenic Shock
- Being tested
- Norepinephrine
- Keywords
- Norepinephrine, Dobutamine, Shock
- Medical subject headings
- Shock, Cardiogenic, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Dobutamine
After obtention of a mean arterial pressure (MAP) of 65 mmHg with infusion of norepinephrine, patients with cardiogenic shock receive for 3 hours either increasing doses of norepinephrine (with a maximal MAP of 85 mmHg) or dobutamine. There is a wash-out phase of 30 minutes (decrease of norepinephrine dose or weaning of dobutamine). The third phase of the study is the administration of the comparator treatment during 3 hours. After the 6.5 hours of the study, the hemodynamic management is up to the physician.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine alone | Experimental | Administration of norepinephrine with increasing dose Receives: Drug: Norepinephrine |
| Norepinephrine plus Dobutamine | Active comparator | Administration of norepinephrine and dobutamine Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtention of a optimal cardiac output
Measure of increase of cardiac index > 15% (L/min/m²), increase of organ perfusion assessed by : lactate clearance > 15% (mmoL/L), decrease of mottling (decrease of 2 points of Mottling score), increase of musculaire oxygen saturation measured by NIRS > 15% (rSo2%), increase of urine output > 50% (mL/h), increase of SVcO2 > 15%(%)
Evaluation of occurence of side effects :
Increase of heart rate > 15% (bpm) , increase of oxygen consumption evaluated by decrease of ratio mean arterial pressure / heart rate > 15% (Buffington ratio).
The primary endpoint is defined by the presence of 2 efficacy criterias without any side effects.
Measured: Hour 0 (H0), Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary outcomes (11)
Change in hemodynamic parameters
Measure of heart rate (bpm),
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Occurence of arrythmia
Notification of atrial arrythmia
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in hemodynamic parameters
Cumulated dose of catecholamines
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
All-cause mortality
Mortality
Measured: Day 28
Change in hemodynamic parameters
Arterial blood pressure (mmHg)
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
SVcO2 (%)
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Lactate clearance (mmol/L)
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Muscular oxygen saturation (%)
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Urine output (mL/h)
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Mottle (mottle score)
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Occurence of arrythmia
Notification of ventricular arrythmia
Measured: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start15 Jan 2018 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3 first hours : strategy 1, norepinephrine alone with increased dose or norepinephrine + dobutamine 0.5 hour : wash-out (decrease of norepinephrine dose or weaning of dobutamine) 3 last hours : strategy 2, crossover, norepinephrine alone with increased dose or norepinephrine + dobutamine
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340779
- Sponsor's protocol ID
- 2017-001270-41
- Other IDs
- 2017
- Acronym
- SHOCK-NORDOB
- Status last verified
- Sep 2017
- First submitted
- 20 Sep 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock : a Randomised, Opened, Cross-over Study. Heart SHOCK-NORDOB Study
- ClinicalTrials.gov ID
- NCT03340779
- Acronym / sponsor ID
- SHOCK-NORDOB / 2017-001270-41
- Conditions
- Cardiogenic Shock
- Keywords
- Norepinephrine, Dobutamine, Shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 14 Nov 2017 (actual)
- 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.
Cardiogenic shock is a frequent cause of admission and death in the intensive care unit.
Mortality is about 50%. Once the etiologic treatment has been done, for instance coronary revascularization, management of the shock state is the cornerstone of the treatment. Norepinephrine is the first-line vasopressor therapy because of its minor effect on heart rhythm. Morever norepinephrine is a inotrope. In a previous study, we demonstrated that increasing the norepinephrine dose increases cardiac index, cardiac power index, SVO2 and tissue perfusion without acceleration of heart rate. Nevertheless, dobutamine remains the first-line inotropic treatment. Dobutamine has a positive chronotropic effect that might cause higher myocardial oxygen consumption. As a result, combination of vasopressor / inotrope is still controversial.
The aim of this study was to compare hemodynamics and metabolics effects of 2 treatments strategies (norepinephrine dose increasing or addition of dobutamine) in patients with cardiogenic shock and optimised blood pressure level (MAP≥65 mmHg) under norepinephrine treatment.
The secondary objectives were :
- To evaluate the efficacy of the treatments on micro- and macrocirculation parameters
- To evaluate the tolerance of the treatments
- To evaluate the dose and the admistration's kinetics of the treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3 first hours : strategy 1, norepinephrine alone with increased dose or norepinephrine + dobutamine 0.5 hour : wash-out (decrease of norepinephrine dose or weaning of dobutamine) 3 last hours : strategy 2, crossover, norepinephrine alone with increased dose or norepinephrine + dobutamine
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine alone | Experimental | Drug: NorepinephrineAdministration of norepinephrine with increasing dose |
| Norepinephrine plus Dobutamine | Active comparator | Drug: NorepinephrineAdministration of norepinephrine and dobutamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with cardiogenic shock (ischemic, rythmic, valvular) defined : by cardiac index (CI) < 2,2 L/min/m² or CI < 2,5 L/min/m² under vasopressor/inotropic treatment and organ hypoperfusion signs : mottles, capillary refill time , urine output < 0,5 mL/kg/hour during at least one hour ou renal replacement therapy, consciouness impairment, pulmonary oedema, hyperlactatemia (> 2 mmoL/L)
- Mean arterial pressure > 65 mmHg under norepinephrine treatment
- Patients with social coverage
- Poisonings with cardiotoxicants
- Patient with intra-aortic ballon pump, extracorporeal life support
Key exclusion criteria (2 listed)
- < 18 years old
- 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 |
|---|---|---|
| NorepinephrineAlso: DobutamineAfter obtention of a mean arterial pressure (MAP) of 65 mmHg with infusion of norepinephrine, patients with cardiogenic shock receive for 3 hours either increasing doses of norepinephrine (with a maximal MAP of 85 mmHg) or dobutamine. There is a wash-out phase of 30 minutes (decrease of norepinephrine dose or weaning of dobutamine). The third phase of the study is the administration of the comparator treatment during 3 hours. After the 6.5 hours of the study, the hemodynamic management is up to the physician. | Drug | Norepinephrine alone, Norepinephrine plus Dobutamine |
Primary outcome
Obtention of a optimal cardiac output
Time frame: Hour 0 (H0), Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Measure of increase of cardiac index > 15% (L/min/m²), increase of organ perfusion assessed by : lactate clearance > 15% (mmoL/L), decrease of mottling (decrease of 2 points of Mottling score), increase of musculaire oxygen saturation measured by NIRS > 15% (rSo2%), increase of urine output > 50% (mL/h), increase of SVcO2 > 15%(%) Evaluation of occurence of side effects : Increase of heart rate > 15% (bpm) , increase of oxygen consumption evaluated by decrease of ratio mean arterial pressure / heart rate > 15% (Buffington ratio). The primary endpoint is defined by the presence of 2 efficacy criterias without any side effects.
11 secondary outcomes
Change in hemodynamic parameters
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Occurence of arrythmia
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in hemodynamic parameters
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
All-cause mortality
Time frame: Day 28
Change in hemodynamic parameters
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Occurence of arrythmia
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: No
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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.
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 Norepinephrine in people with Cardiogenic Shock, run by Central Hospital, Nancy, France 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 6 inclusion and 2 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 14 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtention of a optimal cardiac output (time frame: Hour 0 (H0), Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5). 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 14 Nov 2017.