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

University Hospital, Angers

Status: Completed

Conditions: Mortality; Clinical Trial; Arterial Pressure; Septic Shock; Hemodynamics

Treatments: Drug: maintain mean arterial pressure between 80-85 mm Hg; Other: maintain mean arterial pressure between 65-70 mm Hg

Study type: Interventional

Funder types: Other

Identifiers

NCT01149278

PHRC09-01

Details and patient eligibility

About

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)

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups, including a placebo group

high pressure

Active Comparator group

Treatment:

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

normal pressure

Placebo Comparator group

Treatment:

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