Septic Shock Clinical Trial
— CATSOfficial title:
Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock.
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.
Status | Completed |
Enrollment | 330 |
Est. completion date | December 2005 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Réanimation Médicale - Hôpital Louis Mourier | Colombes | |
France | Réanimation Polyvalente - Hôpital de Corbeil | Corbeil | |
France | Service de Réanimation Médicale - Hôpital Poincaré | Garches | |
France | Réanimation Médicale - Hôpital André Mignot | Le Chesnay | |
France | Réanimation Polyvalente - Hôpital Dupuytren | Limoges | |
France | Réanimation Polyvalente - Hôpital Nord | Marseille | |
France | Réanimation Chirurgicale - Hôpital Central | Nancy | |
France | Service de Réanimation Médicale - Hôpital Central | Nancy | |
France | Réanimation Médicale - Hôpital Georges Pompidou | Paris | |
France | Réanimation Médicale - Hôpital Saint Louis | Paris | |
France | Réanimation Polyvalente - Hôpital Saint Joseph | Paris | |
France | Service d'anesthésiologie - HIA Val de Grâce | Paris | |
France | Réanimation Médicale - CHI de Poissy | Poissy | |
France | Réanimation - CH Victor Provo | Roubaix | |
France | Réanimation Polyvalente - Institut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
University of Versailles | Assistance Publique - Hôpitaux de Paris |
France,
Annane D, Vignon P, Renault A, Bollaert PE, Charpentier C, Martin C, Troché G, Ricard JD, Nitenberg G, Papazian L, Azoulay E, Bellissant E; CATS Study Group. Norepinephrine plus dobutamine versus epinephrine alone for management of septic shock: a randomi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 28 Day mortality | 28 Day | Yes | |
Secondary | -28-day survival distribution | Day 28 | Yes | |
Secondary | -Survival rate at days 14, 28, 90, 6 months and 1 year. | one year | Yes | |
Secondary | -Rate of patients with secondary care limitation | one year | No | |
Secondary | -Organ failure between randomization and day 28. | Day 28 | Yes | |
Secondary | -Serious adverse events between randomization and exit of intensive care unit. | one year | Yes | |
Secondary | -Onset of a reversible clinical event between randomization and exit of intensive care unit (bronchospasm, cutaneous rash, tachycardia) | one year | Yes | |
Secondary | -Time on vasopressors | Day 90 | No | |
Secondary | -Time in intensive care unit | one year | Yes | |
Secondary | -Time in hospital | one year | Yes | |
Secondary | -Costs | Day 90 | No |
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