Comparison of Vasopressin and Other Pressors in Septic Shock

This study has been completed.
Sponsor:
Information provided by:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00269685
First received: December 22, 2005
Last updated: May 26, 2006
Last verified: August 2005
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269685

Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Olivier Lesur, Ph d Centre Hospitalier Universitaire de Sherbrooke
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00269685     History of Changes
Other Study ID Numbers: 00-33-R2
Study First Received: December 22, 2005
Last Updated: May 26, 2006
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 28, 2014