Dopamine and Norepinephrine in Shock Patients

This study has been completed.
Information provided by:
Sepsis Occurrence in Acutely Ill Patients Identifier:
First received: April 12, 2006
Last updated: January 29, 2010
Last verified: April 2006
The purpose of this study is to compare the efficacy of dopamine and norepinephrine, two commonly used vasopressor agents, in the treatment of shock.

Condition Intervention Phase
Drug: dopamine versus norepinephrine
Phase 3

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
Official Title: Comparison of Dopamine and Norepinephrine as the First Vasopressor Agent in the Management of Shock

Resource links provided by NLM:

Further study details as provided by Sepsis Occurrence in Acutely Ill Patients:

Primary Outcome Measures:
  • 28 day survival

Secondary Outcome Measures:
  • ICU survival
  • Hospital survival
  • Severity of organ dysfunction in the ICU (SOFA score)
  • Duration of ICU stay
  • Time spent on vasopressors (vasopressor free days)
  • Time spent on mechanical ventilation (ventilator free days)
  • Time spent on renal replacement (renal replacement free days)
  • Efficacy of dopamine to correct hypotension
  • Hemodynamic effects
  • Concomitant use of dobutamine or other inotropic agents
  • Tolerance: arrhythmia (incidence of ventricular tachycardia, ventricular fibrillation and atrial fibrillation), myocardial necrosis, skin necrosis, limb or distal extremity ischemia.
  • Occurrence of secondary infections
  • Impact of target blood pressure on outcome

Enrollment: 1679
Study Start Date: December 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
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Please refer to this study by its identifier: NCT00314704

University Hospital of Vienna
Vienna, Austria, 1090
CHU Saint Pierre
Brussels, Belgium, 1000
CHU Brugmann
Brussels, Belgium, 1020
HIS Ixelles
Brussels, Belgium, 1050
Erasme University Hospital
Brussels, Belgium, 1070
St Elisabeth
Brussels, Belgium, 1180
CHU Charleroi
Charleroi, Belgium, 6000
Hospital Universitario Rio Hortega
Valladolid, Spain, 47002
Sponsors and Collaborators
Sepsis Occurrence in Acutely Ill Patients
Principal Investigator: Daniel De Backer, MD, PhD SOAP investigators
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00314704     History of Changes
Other Study ID Numbers: SOAP vasopressors 
Study First Received: April 12, 2006
Last Updated: January 29, 2010
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Sepsis Occurrence in Acutely Ill Patients:
circulatory failure
septic shock
cardiogenic shock

Additional relevant MeSH terms:
Pathologic Processes
Dopamine Agents
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasoconstrictor Agents processed this record on May 02, 2016