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

Tracking Information
First Received Date ^ICMJE	June 9, 2010
Last Updated Date	November 2, 2012
Start Date ^ICMJE	March 2010
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 22, 2010)	mortality [ Time Frame: day 28 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01149278 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 22, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock
Official Title ^ICMJE	Not Provided
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)
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Septic Shock Arterial Pressure Hemodynamics Mortality Clinical Trial
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	800
Completion Date	September 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01149278
Other Study ID Numbers ^ICMJE	PHRC09-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Pr ASFAR Pierre, University Hospital, Angers
Study Sponsor ^ICMJE	University Hospital, Angers
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Angers
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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