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

Primary Purpose

Septic Shock, Arterial Pressure, Hemodynamics

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
maintain mean arterial pressure between 80-85 mm Hg
maintain mean arterial pressure between 65-70 mm Hg
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

high pressure

normal pressure

Arm Description

Outcomes

Primary Outcome Measures

mortality

Secondary Outcome Measures

decrease in mortality at day 90
decrease in sequential organ failure assessment
extra renal replacement free days
renal function
amount of fluids
catecholamines free days

Full Information

First Posted
June 9, 2010
Last Updated
November 2, 2012
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01149278
Brief Title
Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock
Acronym
SEPSISPAM
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Angers

4. Oversight

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Arterial Pressure, Hemodynamics, Mortality, Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high pressure
Arm Type
Active Comparator
Arm Title
normal pressure
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
maintain mean arterial pressure between 80-85 mm Hg
Intervention Description
protocolized hemodynamic care aiming to maintain mean arterial pressure between 80-85 mm Hg
Intervention Type
Other
Intervention Name(s)
maintain mean arterial pressure between 65-70 mm Hg
Intervention Description
protocolized hemodynamic care aiming to maintain mean arterial pressure between 65-70 mm Hg
Primary Outcome Measure Information:
Title
mortality
Time Frame
day 28
Secondary Outcome Measure Information:
Title
decrease in mortality at day 90
Time Frame
day 90
Title
decrease in sequential organ failure assessment
Time Frame
day 1 to day 28
Title
extra renal replacement free days
Time Frame
day 28
Title
renal function
Time Frame
day 1 to day 28
Title
amount of fluids
Time Frame
day 1 to end of shock
Title
catecholamines free days
Time Frame
day 1 to day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University hospital Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24635770
Citation
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, Herve 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.
Results Reference
derived

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

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