Back to resultsNorepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock (CATS)
Primary Purpose
Septic Shock, Severe Sepsis, Infections
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
norepinephrine and dobutamine
epinephrine plus placebo of dobutamine
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Catecholamines, Septic shock
Eligibility 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
Sites / Locations
- Réanimation Médicale - Hôpital Louis Mourier
- Réanimation Polyvalente - Hôpital de Corbeil
- Service de Réanimation Médicale - Hôpital Poincaré
- Réanimation Médicale - Hôpital André Mignot
- Réanimation Polyvalente - Hôpital Dupuytren
- Réanimation Polyvalente - Hôpital Nord
- Réanimation Chirurgicale - Hôpital Central
- Service de Réanimation Médicale - Hôpital Central
- Service d'anesthésiologie - HIA Val de Grâce
- Réanimation Médicale - Hôpital Saint Louis
- Réanimation Polyvalente - Hôpital Saint Joseph
- Réanimation Médicale - Hôpital Georges Pompidou
- Réanimation Médicale - CHI de Poissy
- Réanimation - CH Victor Provo
- Réanimation Polyvalente - Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
norepinephrine plus dobutamine
epinephrine
Outcomes
Primary Outcome Measures
28 Day mortality
Secondary Outcome Measures
-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
Full Information
NCT ID
NCT00148278
First Posted
September 1, 2005
Last Updated
July 21, 2010
Sponsor
University of Versailles
Collaborators
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00148278
Brief Title
Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock
Acronym
CATS
Official Title
Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Versailles
Collaborators
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Severe Sepsis, Infections
Keywords
Catecholamines, Septic shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
norepinephrine plus dobutamine
Arm Title
2
Arm Type
Active Comparator
Arm Description
epinephrine
Intervention Type
Drug
Intervention Name(s)
norepinephrine and dobutamine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
epinephrine plus placebo of dobutamine
Intervention Description
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 Measure Information:
Title
28 Day mortality
Time Frame
28 Day
Secondary Outcome Measure Information:
Title
-28-day survival distribution
Time Frame
Day 28
Title
-Survival rate at days 14, 28, 90, 6 months and 1 year.
Time Frame
one year
Title
-Rate of patients with secondary care limitation
Time Frame
one year
Title
-Organ failure between randomization and day 28.
Time Frame
Day 28
Title
-Serious adverse events between randomization and exit of intensive care unit.
Time Frame
one year
Title
-Onset of a reversible clinical event between randomization and exit of intensive care unit (bronchospasm, cutaneous rash, tachycardia)
Time Frame
one year
Title
-Time on vasopressors
Time Frame
Day 90
Title
-Time in intensive care unit
Time Frame
one year
Title
-Time in hospital
Time Frame
one year
Title
-Costs
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djillali Annane, MD, PhD
Organizational Affiliation
Assistance Publique Hôpitaux de Paris - University of Versailles
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eric Bellissant, MD, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Study Chair
Facility Information:
Facility Name
Réanimation Médicale - Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Réanimation Polyvalente - Hôpital de Corbeil
City
Corbeil
ZIP/Postal Code
91100
Country
France
Facility Name
Service de Réanimation Médicale - Hôpital Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Réanimation Médicale - Hôpital André Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Réanimation Polyvalente - Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Réanimation Polyvalente - Hôpital Nord
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Réanimation Chirurgicale - Hôpital Central
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Service de Réanimation Médicale - Hôpital Central
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Service d'anesthésiologie - HIA Val de Grâce
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Réanimation Médicale - Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Réanimation Polyvalente - Hôpital Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Réanimation Médicale - Hôpital Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Réanimation Médicale - CHI de Poissy
City
Poissy
ZIP/Postal Code
78303
Country
France
Facility Name
Réanimation - CH Victor Provo
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Réanimation Polyvalente - Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17720019
Citation
Annane D, Vignon P, Renault A, Bollaert PE, Charpentier C, Martin C, Troche 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 randomised trial. Lancet. 2007 Aug 25;370(9588):676-84. doi: 10.1016/S0140-6736(07)61344-0. Erratum In: Lancet. 2007 Sep 22;370(9592):1034.
Results Reference
result
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Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock
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