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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00148278
• Date of registration: 01/09/2005
• Prospective Registration: No
• Primary sponsor: University of Versailles
• Public title: Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock CATS
• Scientific title: Prospective, Multicenter, Randomized, Double-Blind Study Comparing Safety and Efficacy of Norepinephrine Plus Dobutamine Versus Epinephrine Alone in Septic Shock.
• Date of first enrolment: October 1999
• Target sample size: 330
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00148278
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Eric Bellissant, MD, PhD
• Affiliation: CHU Rennes

• Name: Djillali Annane, MD, PhD
• Affiliation: Assistance Publique Hôpitaux de Paris - University of Versailles

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Septic Shock

Infections

Severe Sepsis

Intervention(s)

Drug: norepinephrine and dobutamine

Drug: epinephrine plus placebo of dobutamine

Primary Outcome(s)

28 Day mortality [Time Frame: 28 Day]

Secondary Outcome(s)

-Onset of a reversible clinical event between randomization and exit of intensive care unit (bronchospasm, cutaneous rash, tachycardia) [Time Frame: one year]

-Costs [Time Frame: Day 90]

-Serious adverse events between randomization and exit of intensive care unit. [Time Frame: one year]

-Time in hospital [Time Frame: one year]

-28-day survival distribution [Time Frame: Day 28]

-Survival rate at days 14, 28, 90, 6 months and 1 year. [Time Frame: one year]

-Organ failure between randomization and day 28. [Time Frame: Day 28]

-Time in intensive care unit [Time Frame: one year]

-Rate of patients with secondary care limitation [Time Frame: one year]

-Time on vasopressors [Time Frame: Day 90]

Secondary ID(s)

AFSSAPS 990931

AOM97123

CIC0203/001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Assistance Publique - Hôpitaux de Paris