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Comparison of Vasopressin and Other Pressors in Septic Shock

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00269685
First Posted: December 23, 2005
Last Update Posted: May 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Université de Sherbrooke
  Purpose

The purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor.

Vasopressin seems to be an interesting alternative in the treatment of septic shock. To this date, available studies have showed that it could correct hyperkinetic syndrome and vasoplegia in septic shocks without noticeable side effect. It as been demonstrated that vasopressin improves renal function, as no effect on digestive organs and as no metabolic effect.


Condition Intervention Phase
Shock, Septic Drug: vasopressin Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • To compare the efficiency of vasopressine to the standard and usual treatment of septic shock on the reverse of the hemodynamic criterion of septic shock

Secondary Outcome Measures:
  • To compare these two categories of treatment on:
  • tonometric parameters
  • renal function
  • in term of tolerance: metabolic effects (increase in lactate and glycaemia), cardiac effects (tachycardia being defined as a heart rate increase of 15%), increase of cardiac enzymes (troponine, CK, CK-MB), and cutanuous vasoconstriction.

Estimated Enrollment: 20
Study Start Date: July 2000
  Eligibility

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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:

  • Legally major patient presenting a septic shock.

The time window between beginning of symptoms and onset of treatment is established at 12 hours.

The patient must be intubated and mechanically ventilated.

Patient presenting a mean arterial blood pressure of less than 60 mm Hg after adequate fluid resuscitation (at least 1 L of colloid or crystalloid) and 10 ug/Kg/min of dopamine.

Patient presenting a cardiac index of at least 3 L/min/m2

Exclusion Criteria:

  • Shock other than septic
  • cardiac hypokinesia
  • a pre-existing organic renal failure that needs hemodyalisis
  • oesophagal or gastric phatology that would lead to a naso-gastric tube contraindication
  Contacts and Locations
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): NCT00269685


Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Olivier Lesur, Ph d Centre de recherche du Centre hospitalier universitaire de Sherbrooke
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00269685     History of Changes
Other Study ID Numbers: 00-33-R2
First Submitted: December 22, 2005
First Posted: December 23, 2005
Last Update Posted: May 29, 2006
Last Verified: August 2005

Keywords provided by Université de Sherbrooke:
Septic shock
catecholamine
vasopressin
tonometria
lactate

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs