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Comparison of Vasopressin and Other Pressors in Septic Shock

Primary Purpose

Shock, Septic

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
vasopressin
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock, Septic focused on measuring Septic shock, catecholamine, vasopressin, tonometria, lactate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    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.

    Full Information

    First Posted
    December 22, 2005
    Last Updated
    May 26, 2006
    Sponsor
    Université de Sherbrooke
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00269685
    Brief Title
    Comparison of Vasopressin and Other Pressors in Septic Shock
    Official Title
    Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Université de Sherbrooke

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shock, Septic
    Keywords
    Septic shock, catecholamine, vasopressin, tonometria, lactate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    vasopressin
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    To compare these two categories of treatment on:
    Title
    tonometric parameters
    Title
    renal function
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olivier Lesur, Ph d
    Organizational Affiliation
    Centre de recherche du Centre hospitalier universitaire de Sherbrooke
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    1597042
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9054839
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8214142
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10528604
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9054835
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10676834
    Citation
    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.
    Results Reference
    background

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    Comparison of Vasopressin and Other Pressors in Septic Shock

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