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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01149278
First received: June 9, 2010
Last updated: November 2, 2012
Last verified: June 2010
June 9, 2010
November 2, 2012
March 2010
September 2012   (Final data collection date for primary outcome measure)
mortality [ Time Frame: day 28 ]
Same as current
Complete list of historical versions of study NCT01149278 on ClinicalTrials.gov Archive Site
  • decrease in mortality at day 90 [ Time Frame: day 90 ]
  • decrease in sequential organ failure assessment [ Time Frame: day 1 to day 28 ]
  • extra renal replacement free days [ Time Frame: day 28 ]
  • renal function [ Time Frame: day 1 to day 28 ]
  • amount of fluids [ Time Frame: day 1 to end of shock ]
  • catecholamines free days [ Time Frame: day 1 to day 28 ]
Same as current
Not Provided
Not Provided
 
Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock
Not Provided
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)
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Septic Shock
  • Arterial Pressure
  • Hemodynamics
  • Mortality
  • Clinical Trial
  • 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
  • Active Comparator: high pressure
    Intervention: Drug: maintain mean arterial pressure between 80-85 mm Hg
  • Placebo Comparator: normal pressure
    Intervention: Other: maintain mean arterial pressure between 65-70 mm Hg
Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Hervé F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01149278
PHRC09-01
Not Provided
Not Provided
Not Provided
Pr ASFAR Pierre, University Hospital, Angers
University Hospital, Angers
Not Provided
Not Provided
University Hospital, Angers
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP