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

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ClinicalTrials.gov Identifier: NCT01149278
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : November 5, 2012
Sponsor:
Information provided by:

Study Description
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)

Condition or disease Intervention/treatment
Septic Shock Arterial Pressure Hemodynamics Mortality Clinical Trial Drug: maintain mean arterial pressure between 80-85 mm Hg Other: maintain mean arterial pressure between 65-70 mm Hg

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2010
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: high pressure Drug: maintain mean arterial pressure between 80-85 mm Hg
protocolized hemodynamic care aiming to maintain mean arterial pressure between 80-85 mm Hg
Placebo Comparator: normal pressure Other: maintain mean arterial pressure between 65-70 mm Hg
protocolized hemodynamic care aiming to maintain mean arterial pressure between 65-70 mm Hg


Outcome Measures

Primary Outcome Measures :
  1. mortality [ Time Frame: day 28 ]

Secondary Outcome Measures :
  1. decrease in mortality at day 90 [ Time Frame: day 90 ]
  2. decrease in sequential organ failure assessment [ Time Frame: day 1 to day 28 ]
  3. extra renal replacement free days [ Time Frame: day 28 ]
  4. renal function [ Time Frame: day 1 to day 28 ]
  5. amount of fluids [ Time Frame: day 1 to end of shock ]
  6. catecholamines free days [ Time Frame: day 1 to day 28 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • moribund
  • absence of registration in french health care system
  • patient protected by law
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149278


Locations
France
University hospital Angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr ASFAR Pierre, University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01149278     History of Changes
Other Study ID Numbers: PHRC09-01
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: November 5, 2012
Last Verified: June 2010

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents