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Clinical Trials/NCT01149278
NCT01149278
Completed
Not Applicable

Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock

University Hospital, Angers1 site in 1 country800 target enrollmentMarch 2010
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ConditionsSeptic ShockArterial PressureHemodynamicsMortalityClinical Trial
Interventionsmaintain mean arterial pressure between 80-85 mm Hgmaintain mean arterial pressure between 65-70 mm Hg
Drugsmaintain mean arterial pressure between 80-85 mm Hg

Overview

Phase
Not Applicable
Intervention
maintain mean arterial pressure between 80-85 mm Hg
Conditions
Septic Shock
Sponsor
University Hospital, Angers
Enrollment
800
Locations
1
Primary Endpoint
mortality
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
September 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Angers

Eligibility Criteria

Inclusion Criteria

  • •patients with septic shock according criteria of Bone
  • •minimal dose of norepinephrine
  • •Written informed consent obtained from the patient or surrogate

Exclusion Criteria

  • •Age \< 18 years
  • •Pregnancy
  • •Participation in other trials with the same endpoints
  • •absence of registration in french health care system
  • •patient protected by law

Arms & Interventions

high pressure

Intervention: maintain mean arterial pressure between 80-85 mm Hg

normal pressure

Intervention: maintain mean arterial pressure between 65-70 mm Hg

Outcomes

Primary Outcomes

mortality

Time Frame: day 28

Secondary Outcomes

  • renal function(day 1 to day 28)
  • decrease in mortality at day 90(day 90)
  • decrease in sequential organ failure assessment(day 1 to day 28)
  • extra renal replacement free days(day 28)
  • amount of fluids(day 1 to end of shock)
  • catecholamines free days(day 1 to day 28)

Study Sites (1)

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