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Dopamine and Norepinephrine in Shock Patients

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ClinicalTrials.gov Identifier: NCT00314704
Recruitment Status : Completed
First Posted : April 14, 2006
Last Update Posted : February 1, 2010
Sponsor:
Information provided by:
Sepsis Occurrence in Acutely Ill Patients

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.

Condition or disease Intervention/treatment Phase
Shock Drug: dopamine versus norepinephrine Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1679 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Dopamine and Norepinephrine as the First Vasopressor Agent in the Management of Shock
Study Start Date : December 2003
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources




Primary Outcome Measures :
  1. 28 day survival

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314704


Locations
Austria
University Hospital of Vienna
Vienna, Austria, 1090
Belgium
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
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

Additional Information:
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
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: February 1, 2010
Last Verified: April 2006

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
Cardiotonic Agents
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
Vasoconstrictor Agents