Comparison of Vasopressin and Other Pressors in Septic Shock - Full Text View

Sponsored by:	Universitaire de Sherbrooke
Information provided by:	Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:	NCT00269685

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 II Phase III

Drug Information available for: Lactic acid Ammonium lactate Argipressin Vasopressins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock

Further study details as provided by Universitaire 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

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

Sponsors and Collaborators

Universitaire de Sherbrooke

Investigators

Principal Investigator:

Olivier Lesur, Ph d

Centre Hospitalier Universitaire de Sherbrooke

More Information

Publications:

[No authors listed] American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992 Jun;20(6):864-74. Review.

Landry DW, Levin HR, Gallant EM, Ashton RC Jr, Seo S, D'Alessandro D, Oz MC, Oliver JA. Vasopressin deficiency contributes to the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1122-5.

Luk J, Ajaelo I, Wong V, Wong J, Chang D, Chou L, Reid IA. Role of V1 receptors in the action of vasopressin on the baroreflex control of heart rate. Am J Physiol. 1993 Sep;265(3 Pt 2):R524-9.

Malay MB, Ashton RC Jr, Landry DW, Townsend RN. Low-dose vasopressin in the treatment of vasodilatory septic shock. J Trauma. 1999 Oct;47(4):699-703; discussion 703-5.

Reid IA. Role of vasopressin deficiency in the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1108-10. Review. No abstract available.

Rozenfeld V, Cheng JW. The role of vasopressin in the treatment of vasodilation in shock states. Ann Pharmacother. 2000 Feb;34(2):250-4. Review.

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

Keywords provided by Universitaire de Sherbrooke:

Septic shock
catecholamine
vasopressin
tonometria
lactate

Study placed in the following topic categories:

Arginine Vasopressin
Systemic Inflammatory Response Syndrome
Sepsis
Shock

Shock, Septic
Vasopressins
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Coagulants
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hematologic Agents

Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Infection
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on January 15, 2009