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

Last updated: February 21, 2025
Sponsor: University Hospital, Angers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Treatment

increase of mean arterial pressure at 65-70 mmHg

increase of mean arterial pressure at 80-85 mmHg

Clinical Study ID

NCT05655065
49RC22_0293
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Anuria

  • Patient with an emergency indication of renal replacement therapy (severehyperkalemia, severe metabolical acidosis with pH <7.15, acute pulmonary edema dueto fluid overload resulting in severe hypoxemia, serum urea concentration > 40mmol/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

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: increase of mean arterial pressure at 65-70 mmHg
Phase:
Study Start date:
January 02, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Angers University Hospital

    Angers,
    France

    Active - Recruiting

  • Vendée Hospital

    La Roche Sur Yon,
    France

    Active - Recruiting

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