MedDataX Logo

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

NCT ID: NCT01149278

Last Updated: 2012-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Septic Shock Arterial Pressure Hemodynamics Mortality Clinical Trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

high pressure

Group Type ACTIVE_COMPARATOR

maintain mean arterial pressure between 80-85 mm Hg

Intervention Type DRUG

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

normal pressure

Group Type PLACEBO_COMPARATOR

maintain mean arterial pressure between 65-70 mm Hg

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

maintain mean arterial pressure between 80-85 mm Hg

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

Intervention Type DRUG

maintain mean arterial pressure between 65-70 mm Hg

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Hospital, Angers

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University hospital Angers

Angers, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Pirracchio R, Fong N, Legrand M. Heterogeneity in the response to a high vs low mean arterial pressure target in patients with septic shock a post hoc analysis of a randomized controlled trial. Intensive Care Med. 2025 Oct;51(10):1775-1783. doi: 10.1007/s00134-025-08104-8. Epub 2025 Sep 17.

Reference Type DERIVED
PMID: 40960603 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24635770 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PHRC09-01

Identifier Type: -

Identifier Source: org_study_id