Effects of Increasing Mean Arterial Pressure on Renal Function in Patients with Shock and with Elevated Central Venous Pressure

NCT ID: NCT05655065

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of this study is to assess the effect of a higher mean arterial pressure on renal function for patients with shock and elevated central venous pressure.

Detailed Description

Current recommandation for mean arterial pressure (MAP) target is 65 mmHg for septic shock, but optimal target to prevent acute renal failure (ARF) remains unknown.

High central venous pressure (CVP) can lead to acute renal failure through venous congestion , and is associated with acute renal failure in intensive care unit.

A decrease of renal perfusion pressure, defined by MAP - CVP, has been shown to be associated with risk of acute renal failure.

The main objective of this trial is to evaluate if an optimisation of renal perfusion pressure, by a higher MAP when CVP is high (≥ 12 cmH2O), can improve renal function.

In this interventional monocenter trial, each patient will be evaluated during 2 consecutive periods of 6 hours, with a temporary MAP target

• Target at 65-70mmHg during 6 hours
• Target at 80-85mmHg during 6 hours

Patients will be randomized into two groups to define the order of targets. There will be a stratification on previous arterial hypertension. Renal function will be measured at the end of each period.

Conditions

Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Increase of MAP at low target 65-70 mmHg (with catecholamines or volemic expansion)

Target of mean arterial pressure (MAP) at 65-70 mmHg The therapeutic means used to obtain the MAP objectives within each group (increase in catecholamines and / or volume expansion) are left to the discretion of the clinician, in accordance with the recommendations.

Group Type: ACTIVE_COMPARATOR

increase of mean arterial pressure at 65-70 mmHg

Intervention Type: PROCEDURE

Increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion at the discretion of the clinician)

Increase of MAP at high target 80-85 mmHg (with catecholamines or volemic expansion)

Target of mean arterial pressure (MAP) at 80-85 mmHg The therapeutic means used to obtain the MAP objectives within each group (increase in catecholamines and / or volume expansion) are left to the discretion of the clinician, in accordance with the recommendations.

Group Type: EXPERIMENTAL

increase of mean arterial pressure at 80-85 mmHg

Intervention Type: PROCEDURE

Increase of mean arterial pressure at 80-85mmHg (with catecholamines or volemic expansion at the discretion of the clinician).

Interventions

increase of mean arterial pressure at 65-70 mmHg

Increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion at the discretion of the clinician)

Intervention Type: PROCEDURE

increase of mean arterial pressure at 80-85 mmHg

Increase of mean arterial pressure at 80-85mmHg (with catecholamines or volemic expansion at the discretion of the clinician).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥ 18 years old )
• Arterial hypotension requiring the etablishment of catecholamines
• Norepinephrine dose ⩾ 0.1µg/kg/min at the inclusion
• High central venous pressure ≥ 12mmHg
• Cardiac output monitoring (PICCO or Swan Ganz)

Exclusion Criteria

• Anuria
• Patient with an emergency indication of renal replacement therapy (severe hyperkalemia, severe metabolical acidosis with pH <7.15, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration > 40 mmol/l)
• Pregnant, lactating or parturient woman
• Patient deprived of liberty by judicial or administrative decision
• Patient with psychiatric compulsory care
• Patient subject to legal protection measures
• Patients with do-no-reanimate order or withdrawal of life sustaining support

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre ASFAR, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Angers University Hospital

Locations

Angers University Hospital

Angers, , France

Site Status: RECRUITING

Vendée Hospital

La Roche-sur-Yon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas FAGE, MD

Role: CONTACT

nicolas.fage@chu-angers.fr

+332 41 35 36 37

Ines ZIRIAT, MD

Role: CONTACT

+332 41 35 36 37

Facility Contacts

Pierre ASFAR

Role: primary

PiAsfar@chu-angers.fr

02 41 35 58 65

Jean-Claude LACHERADE

Role: primary

Jean-claude.lacherade@ght85.fr

02 51 44 61 61

Other Identifiers

49RC22_0293

Identifier Type: -

Identifier Source: org_study_id