Comparison of Vasopressin and Other Pressors in Septic Shock | NCT00269685

Studies
Comparison of Vasopressin and Other Pressors in Septic Shock

NCT00269685

Sponsor

Université de Sherbrooke

Status

Completed

Last Update Posted

May 29, 2006Estimated

Enrollment

Phase

Phase 2Phase 3

Conditions

Shock, Septic

Interventions

vasopressin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2000

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 22, 2005

First Submission Date that Met QC Criteria

Dec 22, 2005

First Posted Date

Dec 23, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2006

Last Update Posted Date

May 29, 2006Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
vasopressin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To compare these two categories of treatment on:
tonometric parameters
renal function

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier Lesur, Ph d	Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1597042	Background	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.
9054839	Background	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.

ID	Term
D012772	Shock, Septic
D003919	Diabetes Insipidus

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones