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Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock (CATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148278
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : July 22, 2010
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Versailles

Brief 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.

Condition or disease Intervention/treatment Phase
Septic Shock Severe Sepsis Infections Drug: norepinephrine and dobutamine Drug: epinephrine plus placebo of dobutamine Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock.
Study Start Date : October 1999
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2005

Arm Intervention/treatment
Experimental: 1
norepinephrine plus dobutamine
Drug: norepinephrine and dobutamine
continuous infusion of norepinephrine titrated to maintain a mean arterial pressure at 70mmHg or more and dobutamine could be added as a continuous infusion when cardiac index was of less than 2.5 liters per squared meter of body surface

Active Comparator: 2
Drug: epinephrine plus placebo of dobutamine
epinephrine was titrated to maintain a mean arterial pressure at 70mmHg or more and placebo of dobutamine was titrated in case of a cardiac index lower than 2.5 liters per squared meters of body surface

Primary Outcome Measures :
  1. 28 Day mortality [ Time Frame: 28 Day ]

Secondary Outcome Measures :
  1. -28-day survival distribution [ Time Frame: Day 28 ]
  2. -Survival rate at days 14, 28, 90, 6 months and 1 year. [ Time Frame: one year ]
  3. -Rate of patients with secondary care limitation [ Time Frame: one year ]
  4. -Organ failure between randomization and day 28. [ Time Frame: Day 28 ]
  5. -Serious adverse events between randomization and exit of intensive care unit. [ Time Frame: one year ]
  6. -Onset of a reversible clinical event between randomization and exit of intensive care unit (bronchospasm, cutaneous rash, tachycardia) [ Time Frame: one year ]
  7. -Time on vasopressors [ Time Frame: Day 90 ]
  8. -Time in intensive care unit [ Time Frame: one year ]
  9. -Time in hospital [ Time Frame: one year ]
  10. -Costs [ Time Frame: Day 90 ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00148278

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Réanimation Médicale - Hôpital Louis Mourier
Colombes, France, 92700
Réanimation Polyvalente - Hôpital de Corbeil
Corbeil, France, 91100
Service de Réanimation Médicale - Hôpital Poincaré
Garches, France, 92380
Réanimation Médicale - Hôpital André Mignot
Le Chesnay, France, 78157
Réanimation Polyvalente - Hôpital Dupuytren
Limoges, France, 87000
Réanimation Polyvalente - Hôpital Nord
Marseille, France, 13009
Réanimation Chirurgicale - Hôpital Central
Nancy, France, 54035
Service de Réanimation Médicale - Hôpital Central
Nancy, France, 54035
Service d'anesthésiologie - HIA Val de Grâce
Paris, France, 75005
Réanimation Médicale - Hôpital Saint Louis
Paris, France, 75010
Réanimation Polyvalente - Hôpital Saint Joseph
Paris, France, 75014
Réanimation Médicale - Hôpital Georges Pompidou
Paris, France, 75908
Réanimation Médicale - CHI de Poissy
Poissy, France, 78303
Réanimation - CH Victor Provo
Roubaix, France, 59100
Réanimation Polyvalente - Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
University of Versailles
Assistance Publique - Hôpitaux de Paris
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Study Director: Djillali Annane, MD, PhD Assistance Publique Hôpitaux de Paris - University of Versailles
Study Chair: Eric Bellissant, MD, PhD CHU Rennes
Publications of Results:
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Responsible Party: Djillali Annane, Assistance Publique Hôpitaux de Paris Identifier: NCT00148278    
Other Study ID Numbers: AFSSAPS 990931
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010
Keywords provided by University of Versailles:
Septic shock
Additional relevant MeSH terms:
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Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents
Cardiotonic Agents
Adrenergic beta-1 Receptor Agonists
Protective Agents