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

NCT05655065 | Recruiting

• 1 other identifier: 49RC22_0293
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Shock

Keywords

mean arterial pressure; central venous pressure; Renal function

Outcome Measures

Primary Outcomes (1)

• Changes of creatinine clearance

  Creatinine clearance is calculated with the formula UV/P as follow : * U being the urinary creatinine concentration in μmol/l * V the urinary volume expressed in ml per unit time * P the plasmatic creatinine concentration in μmol/l

  At 6 hours and at 12 hours

Secondary Outcomes (30)

• Changes of renal resistive index

  At 6 hours and 12 hours

• Co-morbidities

  At inclusion.

• Arterial hypertension treatment

  At inclusion.

• Introduction time of norepinephrine

  At inclusion

• Norepinephrine dose

  At inclusion, then every hours up to hour 12

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Procedure: increase of mean arterial pressure at 65-70 mmHg

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

EXPERIMENTAL

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.

Procedure: increase of mean arterial pressure at 80-85 mmHg

Interventions

increase of mean arterial pressure at 65-70 mmHg 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 low target 65-70 mmHg (with catecholamines or volemic expansion)

increase of mean arterial pressure at 80-85 mmHg PROCEDURE

Increase of mean arterial pressure at 80-85mmHg (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)

Eligibility Criteria

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

You may qualify if:

• Adult patients (≥ 18 years old )
• Arterial hypotension requiring the etablishment of catecholamines
• High central venous pressure ≥ 12mmHg
• Cardiac output monitoring (PICCO or Swan Ganz)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (2)

Angers University Hospital

Angers, France

RECRUITING

Vendée Hospital

La Roche-sur-Yon, France

RECRUITING

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre ASFAR, MD PhD

  Angers University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas FAGE, MD

CONTACT

+332 41 35 36 37; nicolas.fage@chu-angers.fr

Ines ZIRIAT, MD

CONTACT

+332 41 35 36 37

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: December 16, 2022
• Study Start: January 2, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

FR (2)