Trials Sponsors Conditions Drugs Pricing

Conditions

Infections Septic Shock Severe Sepsis

Keywords

CatecholaminesSeptic shock

Outcome Measures

Primary Outcomes (1)

28 Day mortality
28 Day

Secondary Outcomes (10)

-28-day survival distribution
Day 28
-Survival rate at days 14, 28, 90, 6 months and 1 year.
one year
-Rate of patients with secondary care limitation
one year
-Organ failure between randomization and day 28.
Day 28
-Serious adverse events between randomization and exit of intensive care unit.
one year
+5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

norepinephrine plus dobutamine

Drug: norepinephrine and dobutamine

2

ACTIVE COMPARATOR

epinephrine

Drug: epinephrine plus placebo of dobutamine

Interventions

norepinephrine and dobutamineDrug

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

epinephrine plus placebo of dobutamineDrug

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

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
norepinephrine and dobutamine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults over 18 years
Informed consent

Sponsors & Collaborators

University of Versailles
Otherlead
Assistance Publique - Hôpitaux de Paris
Othercollaborator

Study Sites (15)

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

Related Publications (1)

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.
PMID: 17720019RESULT

MeSH Terms

Conditions

Shock, SepticSepsisInfections

Interventions

NorepinephrineDobutamineEpinephrine

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

EthanolaminesAmino Alcohols

Study Officials

Djillali Annane, MD, PhD
Assistance Publique Hôpitaux de Paris - University of Versailles
STUDY DIRECTOR
Eric Bellissant, MD, PhD
Rennes University Hospital
STUDY CHAIR

Enrollment

330 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 7, 2005

Study Start

October 1999

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

1

2

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

1

2

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations