Comparison of Vasopressin and Other Pressors in Septic Shock

Phase 2

Completed

• Conditions: Shock, Septic

• Registration Number: NCT00269685
• Lead Sponsor: Université de Sherbrooke

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

Not available

Study Timeline

• Study Start: 2000-07
• Status Verified: 2005-08
• Study First Submitted: 2005-12-22
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-23
• Last Update Submitted: 2006-05-26
• Last Update Posted: 2006-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.