Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock
Information source: University of Versailles
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock; Severe Sepsis; Infections
Intervention: norepinephrine and dobutamine (Drug); epinephrine plus placebo of dobutamine (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: University of Versailles Official(s) and/or principal investigator(s): Djillali Annane, MD, PhD, Study Director, Affiliation: Assistance Publique Hôpitaux de Paris - University of Versailles Eric Bellissant, MD, PhD, Study Chair, Affiliation: CHU Rennes
Summary
Catecholamines infusion is a major component of septic shock management. International
guidelines recommend that norepinephrine should be preferred to epinephrine, though phase
III trials are lacking. The present study aimed at comparing the efficacy and safety of
norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.
Clinical Details
Official title: Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 28 Day mortality
Secondary outcome: -28-day survival distribution-Survival rate at days 14, 28, 90, 6 months and 1 year. -Rate of patients with secondary care limitation -Organ failure between randomization and day 28. -Serious adverse events between randomization and exit of intensive care unit. -Onset of a reversible clinical event between randomization and exit of intensive care unit (bronchospasm, cutaneous rash, tachycardia) -Time on vasopressors -Time in intensive care unit -Time in hospital -Costs
Detailed description:
The french Conference on Consensus on catecholamines use in septic shock has underlined the
importance of carrying out a clinical trial to clarify the use of epinephrine,
norepinephrine and dobutamine in the management of multiple organ failure associated with
severe sepsis. The main objective of the study was therefore to compare the effects of the
combination of dobutamine and norepinephrine to those of epinephrine alone in patients with
septic shock. In this purpose, patients were randomly assigned to receive either epinephrine
or norepinephrine plus dobutamine and drugs were titrated to maintain blood pressure over 70
mmHg. Main outcome was 28-day mortality.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults over 18 years
- Informed consent
Presenting from less than 7 days :
- One or more infectious site
- At least 2 of the following criteria: temperature > 38°C or < 36. 5°C, respiratory
rate > 20 breaths per min or PaCO2 < 32 mmHg or mechanical ventilation, heart rate >
90 beats/min, white blood cell count > 12,000/mm3 or < 4,000/mm3
- At least 2 of the following criteria: PaO2/FiO2 ratio <280 mmHg (if mechanical
ventilation, urinary output of less than 0. 5 mL/kg of body weight or < 30 mL/h at
least 1 hour, plasma lactate > 2 mmol/L, platelet count < 100,000 /mm3
And presenting from at least 24 hours:
- Systolic blood pressure < 90 mmHg or mean blood pressure < 70 mmHg (for at least 30
min);
- 1000 mL fluid replacement or pulmonary capillary wedge pressure > 12 mmHg
- Dopamine infusion at 15 µg/kg/min for at least 1 hour, or epinephrine or
norepinephrine in first intention
Exclusion Criteria:
- Pregnant woman
- Obstructive cardiomyopathy
- Acute coronary disease
- Non infectious shock
- Care limitation
- White blood cell count < 500 /mm3
Locations and Contacts
Réanimation Médicale - Hôpital Louis Mourier, Colombes 92700, France
Réanimation Polyvalente - Hôpital de Corbeil, Corbeil 91100, France
Service de Réanimation Médicale - Hôpital Poincaré, Garches 92380, France
Réanimation Médicale - Hôpital André Mignot, Le Chesnay 78157, France
Réanimation Polyvalente - Hôpital Dupuytren, Limoges 87000, France
Réanimation Polyvalente - Hôpital Nord, Marseille 13009, France
Réanimation Chirurgicale - Hôpital Central, Nancy 54035, France
Service de Réanimation Médicale - Hôpital Central, Nancy 54035, France
Réanimation Médicale - Hôpital Georges Pompidou, Paris 75908, France
Réanimation Médicale - Hôpital Saint Louis, Paris 75010, France
Réanimation Polyvalente - Hôpital Saint Joseph, Paris 75014, France
Service d'anesthésiologie - HIA Val de Grâce, Paris 75005, France
Réanimation Médicale - CHI de Poissy, Poissy 78303, France
Réanimation - CH Victor Provo, Roubaix 59100, France
Réanimation Polyvalente - Institut Gustave Roussy, Villejuif 94800, France
Additional Information
Starting date: October 1999
Last updated: July 21, 2010
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