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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
History of Changes
  Purpose

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 Intervention
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • mortality [ Time Frame: day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • decrease in mortality at day 90 [ Time Frame: day 90 ] [ Designated as safety issue: Yes ]
  • decrease in sequential organ failure assessment [ Time Frame: day 1 to day 28 ] [ Designated as safety issue: Yes ]
  • extra renal replacement free days [ Time Frame: day 28 ] [ Designated as safety issue: Yes ]
  • renal function [ Time Frame: day 1 to day 28 ] [ Designated as safety issue: Yes ]
  • amount of fluids [ Time Frame: day 1 to end of shock ] [ Designated as safety issue: Yes ]
  • catecholamines free days [ Time Frame: day 1 to day 28 ] [ Designated as safety issue: Yes ]

Enrollment: 800
Study Start Date: March 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149278

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

No publications provided

Responsible Party: Pr ASFAR Pierre, University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01149278     History of Changes
Other Study ID Numbers: PHRC09-01
Study First Received: June 9, 2010
Last Updated: November 2, 2012
Health Authority: France: Ministry of Health

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013