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

Not Applicable

Completed

• Conditions: Septic Shock; Arterial Pressure; Hemodynamics; Mortality; Clinical Trial
• Interventions: Drug: maintain mean arterial pressure between 80-85 mm Hg; Other: maintain mean arterial pressure between 65-70 mm Hg

• Registration Number: NCT01149278
• Lead Sponsor: University Hospital, Angers

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Status Verified: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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
• moribund
• absence of registration in french health care system
• patient protected by law

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high pressure	maintain mean arterial pressure between 80-85 mm Hg	-
normal pressure	maintain mean arterial pressure between 65-70 mm Hg	-

Primary Outcome Measures

Name	Time	Method
mortality	day 28

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University hospital Angers; 🇫🇷 Angers, France