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

Septic Shock Clinical Trial

— SEPSISPAM  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149278
• Other study ID #: PHRC09-01
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: November 2, 2012
• Start date: March 2010
• Est. completion date: September 2012

Study information

• Verified date: June 2010
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Pressure
• Clinical Trial
• Hemodynamics
• Mortality
• Septic Shock
• Shock, Septic

Intervention

Drug:
• maintain mean arterial pressure between 80-85 mm Hg
protocolized hemodynamic care aiming to maintain mean arterial pressure between 80-85 mm Hg

Other:
• maintain mean arterial pressure between 65-70 mm Hg
protocolized hemodynamic care aiming to maintain mean arterial pressure between 65-70 mm Hg

Locations

Country	Name	City	State
France	University hospital Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		day 28	Yes
Secondary	decrease in mortality at day 90		day 90	Yes
Secondary	decrease in sequential organ failure assessment		day 1 to day 28	Yes
Secondary	extra renal replacement free days		day 28	Yes
Secondary	renal function		day 1 to day 28	Yes
Secondary	amount of fluids		day 1 to end of shock	Yes
Secondary	catecholamines free days		day 1 to day 28	Yes