Text Size

Dopamine and Norepinephrine in Shock Patients

This study has been completed.
Sponsor:
Information provided by:
Sepsis Occurrence in Acutely Ill Patients
ClinicalTrials.gov Identifier:
NCT00314704
First received: April 12, 2006
Last updated: January 29, 2010
Last verified: April 2006
History of Changes
  Purpose

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
Shock
 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:

U.S. FDA Resources

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)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314704

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

Additional Information:
Click here for more information about this study: Dopamine and norepinephrine as the first vasoactive agent  This link exits the ClinicalTrials.gov site

No publications provided by Sepsis Occurrence in Acutely Ill Patients

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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: Directorate general for the protection of Public health: Medicines

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

Additional relevant MeSH terms:
Shock
Pathologic Processes
Dopamine
Norepinephrine
Dopamine Agents
Vasoconstrictor Agents
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on May 23, 2013