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Trial record 5 of 322 for:    Recruiting, Not yet recruiting, Available Studies | "Shock"

Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock (SHOCK-NORDOB)

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ClinicalTrials.gov Identifier: NCT03340779
Recruitment Status : Not yet recruiting
First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief 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. 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

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Drug: Norepinephrine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock : a Randomised, Opened, Cross-over Study. Heart SHOCK-NORDOB Study
Estimated Study Start Date : January 15, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Norepinephrine alone
Administration of norepinephrine with increasing dose
Drug: Norepinephrine
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.
Other Name: Dobutamine

Active Comparator: Norepinephrine plus Dobutamine
Administration of norepinephrine and dobutamine
Drug: Norepinephrine
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.
Other Name: Dobutamine




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Change in hemodynamic parameters [ Time Frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 ]
    Measure of heart rate (bpm),

  2. Occurence of arrythmia [ Time Frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 ]
    Notification of atrial arrythmia

  3. Change in hemodynamic parameters [ Time Frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 ]
    Cumulated dose of catecholamines

  4. All-cause mortality [ Time Frame: Day 28 ]
    Mortality

  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 ]
    Arterial blood pressure (mmHg)

  6. Change in metabolic parameters [ Time Frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 ]
    SVcO2 (%)

  7. Change in metabolic parameters [ Time Frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 ]
    Lactate clearance (mmol/L)

  8. Change in metabolic parameters [ Time Frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 ]
    Muscular oxygen saturation (%)

  9. Change in metabolic parameters [ Time Frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 ]
    Urine output (mL/h)

  10. Change in metabolic parameters [ Time Frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 ]
    Mottle (mottle score)

  11. Occurence of arrythmia [ Time Frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5 ]
    Notification of ventricular arrythmia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • < 18 years old
  • Pregnancy
  • Inclusion in other drug study
  • Poisonings with cardiotoxicants
  • Patient with intra-aortic ballon pump, extracorporeal life support
  • Patient under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340779


Locations
France
CHU Nancy-Brabois Not yet recruiting
Vandoeuvre les nancy, France, 54500
Contact: Thomas Auchet, MD    033383157022    t.auchet@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03340779     History of Changes
Other Study ID Numbers: 2017-001270-41
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
Norepinephrine
Dobutamine
Shock

Additional relevant MeSH terms:
Shock
Shock, Cardiogenic
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Norepinephrine
Dobutamine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiotonic Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Protective Agents