Comparison of Vasopressin and Other Pressors in Septic Shock - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 22, 2005

Last Updated Date

May 26, 2006

Start Date ^†

July 2000

Current 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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00269685 on ClinicalTrials.gov Archive Site

Current 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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Comparison of Vasopressin and Other Pressors in Septic Shock

Official Title ^†

Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock

Brief Summary

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Condition ^†

Shock, Septic

Intervention ^†

Drug: vasopressin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00269685

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Universitaire de Sherbrooke

Collaborators ^††

Investigators ^†

Principal Investigator:

Olivier Lesur, Ph d

Centre Hospitalier Universitaire de Sherbrooke

Information Provided By

Universitaire de Sherbrooke

Verification Date

August 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.