A Phase 3 interventional study of Norepinephrine in Cardiogenic Shock, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by Central Hospital, Nancy, France · Phase 3, Interventional, and Treatment
Among 12 studies in Shock, Cardiogenic by Central Hospital, Nancy, France — 2 open to participants now, 3 under way, 1 of them phase 3. Shock, Cardiogenic · Central Hospital, Nancy, France.
Among the 12 studies in Shock, Cardiogenic by Central Hospital, Nancy, France, this one is one of 2 that started in 2018, is one of 2 in phase 3, and was the 4th registered.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
Browse Shock, Cardiogenic studies →2 of the 12 studies in Shock, Cardiogenic by Central Hospital, Nancy, France are open now, in 1 country. Recruiting first, the newest first:
Central Hospital, Nancy, France · Sites in France
Ages 18+
Central Hospital, Nancy, France
Ages 18–90
By country, each count listing its studies:
Of the 102 Shock, Cardiogenic studies recruiting now, 70 (69%) set no upper age limit and 9 (9%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Median enrollment 58 across the 5 interventional studies, 300 across the 7 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
1 of the studies in Shock, Cardiogenic by Central Hospital, Nancy, France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05879276Phase 3Central Hospital, Nancy, FranceEffect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function. | 2027-03-16 |
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Among the 12 studies in Shock, Cardiogenic by Central Hospital, Nancy, France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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 :
Inclusion Criteria:
Exclusion Criteria:
Administration of norepinephrine with increasing dose
Drug: Norepinephrine
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.
Also known as: Dobutamine
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.
Time frame: Hour 0 (H0), Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in hemodynamic parameters
Measure of heart rate (bpm),
Time frame: 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
Time frame: 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
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
All-cause mortality
Mortality
Time frame: Day 28
Change in hemodynamic parameters
Arterial blood pressure (mmHg)
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Change in metabolic parameters
SVcO2 (%)
Time frame: 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)
Time frame: 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 (%)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Hour 0, Hour 1, Hour 3, Hour 3.5, Hour 4,5, Hour 5.5, Hour 6.5
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2018; primary completion for Nov 2019, 21 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Norepinephrine
Central Hospital, Nancy, France →