NCT00314704

Brief Summary

The purpose of this study is to compare the efficacy of dopamine and norepinephrine, two commonly used vasopressor agents, in the treatment of shock.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,679

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2003

Typical duration for phase_3

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 1, 2010

Status Verified

April 1, 2006

Enrollment Period

3.8 years

First QC Date

April 12, 2006

Last Update Submit

January 29, 2010

Conditions

Shock

Keywords

shockhypotensioncirculatory failureseptic shockcardiogenic shock

Outcome Measures

Primary Outcomes (1)

  • 28 day survival

Secondary Outcomes (13)

  • ICU survival

  • Hospital survival

  • Severity of organ dysfunction in the ICU (SOFA score)

  • Duration of ICU stay

  • Time spent on vasopressors (vasopressor free days)

  • +8 more secondary outcomes

Interventions

dopamine versus norepinephrineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mean arterial pressure less than 70 mmHg or systolic pressure less than 100 mmHg persisting despite adequate fluid loading (in example with at least 1000 mL crystalloid or 500 ml colloid) unless central venous pressure (CVP) or pulmonary artery occluded pressure (PAOP) are elevated (e.g. CVP\> 12 mmHg or PAOP \> 14 mmHg).

You may not qualify if:

  • Serious arrhythmia such as rapid atrial fibrillation (\> 160/min) or ventricular tachycardia.
  • Brain death.
  • Open label administration of dopamine, norepinephrine, epinephrine or phenylephrine for more than 4hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Hospital of Vienna

Vienna, 1090, Austria

Location

CHU Saint Pierre

Brussels, 1000, Belgium

Location

CHU Brugmann

Brussels, 1020, Belgium

Location

HIS Ixelles

Brussels, 1050, Belgium

Location

Erasme University Hospital

Brussels, 1070, Belgium

Location

St Elisabeth

Brussels, 1180, Belgium

Location

CHU Charleroi

Charleroi, 6000, Belgium

Location

Hospital Universitario Rio Hortega

Valladolid, 47002, Spain

Location

Related Publications (1)

  • De Backer D, Biston P, Devriendt J, Madl C, Chochrad D, Aldecoa C, Brasseur A, Defrance P, Gottignies P, Vincent JL; SOAP II Investigators. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med. 2010 Mar 4;362(9):779-89. doi: 10.1056/NEJMoa0907118.

    PMID: 20200382DERIVED

Related Links

MeSH Terms

Conditions

ShockHypotensionShock, SepticShock, Cardiogenic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesSepsisInfectionsSystemic Inflammatory Response SyndromeInflammationMyocardial InfarctionMyocardial IschemiaHeart DiseasesInfarctionIschemiaNecrosis

Study Officials

  • Daniel De Backer, MD, PhD

    SOAP investigators

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 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

April 12, 2006

First Posted

April 14, 2006

Study Start

December 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 1, 2010

Record last verified: 2006-04

Locations

BE(6)ES(1)AU(1)