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

NCT01149278 | Completed

• 1 other identifier: PHRC09-01
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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)

Conditions

Septic Shock; Arterial Pressure; Hemodynamics; Mortality; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• mortality

  day 28

Secondary Outcomes (6)

• decrease in mortality at day 90

  day 90

• decrease in sequential organ failure assessment

  day 1 to day 28

• extra renal replacement free days

  day 28

• renal function

  day 1 to day 28

• amount of fluids

  day 1 to end of shock

Study Arms (2)

high pressure

ACTIVE COMPARATOR

Drug: maintain mean arterial pressure between 80-85 mm Hg

normal pressure

PLACEBO COMPARATOR

Other: maintain mean arterial pressure between 65-70 mm Hg

Interventions

maintain mean arterial pressure between 80-85 mm Hg DRUG

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

high pressure

maintain mean arterial pressure between 65-70 mm Hg OTHER

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

normal pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with septic shock according criteria of Bone
• minimal dose of norepinephrine
• Written informed consent obtained from the patient or surrogate

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University hospital Angers

Angers, 49933, France

Location

Related Publications (2)

• 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.

  PMID: 40960603 DERIVED

• 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.

  PMID: 24635770 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 23, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 5, 2012

Record last verified: 2010-06

Locations

FR (1)