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Clinical Trials/NCT00269685
NCT00269685CompletedPhase 2

Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock

Université de Sherbrooke0 sites20 target enrollmentStarted: July 1, 2000Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
20
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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.

Investigators

Sponsor Class
Other

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