Arterial Pressure, Clinical Trial, Hemodynamics, Mortality, Septic Shock
Conditions
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)
Interventions
DRUGmaintain mean arterial pressure between 80-85 mm Hg
protocolized hemodynamic care aiming to maintain mean arterial pressure between 80-85 mm Hg
OTHERmaintain mean arterial pressure between 65-70 mm Hg
protocolized hemodynamic care aiming to maintain mean arterial pressure between 65-70 mm Hg
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality | day 28 |
Secondary
| Measure | Time frame |
|---|---|
| decrease in sequential organ failure assessment | day 1 to day 28 |
| extra renal replacement free days | day 28 |
| decrease in mortality at day 90 | day 90 |
| amount of fluids | day 1 to end of shock |
| catecholamines free days | day 1 to day 28 |
| renal function | day 1 to day 28 |
Countries
France
Outcome results
None listed