Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock

Cardiogenic Shock Clinical Trial

— SHOCK-NORDOB  

Official title:

Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock : a Randomised, Opened, Cross-over Study. Heart SHOCK-NORDOB Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03340779
• Other study ID #: 2017-001270-41
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 20, 2017
• Last updated: November 8, 2017
• Start date: January 15, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: September 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

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.

Locations

Country	Name	City	State
France	CHU Nancy-Brabois	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Hour 0 (H0), Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	Change in hemodynamic parameters	Measure of heart rate (bpm),	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	Occurence of arrythmia	Notification of atrial arrythmia	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	Change in hemodynamic parameters	Cumulated dose of catecholamines	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	All-cause mortality	Mortality	Day 28
Secondary	Change in hemodynamic parameters	Arterial blood pressure (mmHg)	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	Change in metabolic parameters	SVcO2 (%)	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	Change in metabolic parameters	Lactate clearance (mmol/L)	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	Change in metabolic parameters	Muscular oxygen saturation (%)	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	Change in metabolic parameters	Urine output (mL/h)	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	Change in metabolic parameters	Mottle (mottle score)	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Secondary	Occurence of arrythmia	Notification of ventricular arrythmia	Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5