Comparison of Vasopressin and Other Pressors in Septic Shock

NCT ID: NCT00269685

Last Updated: 2006-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Brief Summary

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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

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Conditions

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Shock, Septic

Keywords

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Septic shock catecholamine vasopressin tonometria lactate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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vasopressin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Principal Investigators

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Olivier Lesur, Ph d

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

References

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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.

Reference Type BACKGROUND
PMID: 1597042 (View on PubMed)

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. doi: 10.1161/01.cir.95.5.1122.

Reference Type BACKGROUND
PMID: 9054839 (View on PubMed)

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. doi: 10.1152/ajpregu.1993.265.3.R524.

Reference Type BACKGROUND
PMID: 8214142 (View on PubMed)

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. doi: 10.1097/00005373-199910000-00014.

Reference Type BACKGROUND
PMID: 10528604 (View on PubMed)

Reid IA. Role of vasopressin deficiency in the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1108-10. doi: 10.1161/01.cir.95.5.1108. No abstract available.

Reference Type BACKGROUND
PMID: 9054835 (View on PubMed)

Rozenfeld V, Cheng JW. The role of vasopressin in the treatment of vasodilation in shock states. Ann Pharmacother. 2000 Feb;34(2):250-4. doi: 10.1345/aph.19066.

Reference Type BACKGROUND
PMID: 10676834 (View on PubMed)

Other Identifiers

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00-33-R2

Identifier Type: -

Identifier Source: org_study_id