Comparison of Vasopressin and Other Pressors in Septic Shock

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT00269685

Collaborator

(none)

Enrollment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shock, Septic	Drug: vasopressin	Phase 2/Phase 3

Study Design

Study Type:

Interventional

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

Study Start Date :

Jul 1, 2000

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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