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Completed

NCT Number: NCT01149278

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

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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Key information

Conditions

Septic Shock Arterial Pressure Clinical Trial Hemodynamics Infections Inflammation Mortality Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Angers

Angers, 49933, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

maintain mean arterial pressure between 80-85 mm Hg

Drug

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

maintain mean arterial pressure between 65-70 mm Hg

Other

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

Primary outcomes

  1. mortality

    Time frame: day 28

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: SEPSISPAM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 23, 2010
Registry last updated
Nov 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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