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NCT05655065 | RECRUITING | Shock

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

University Hospital, Angers

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.

Condition or disease

Shock

Intervention/treatment

increase of mean arterial pressure at 65-70 mmHg

increase of mean arterial pressure at 80-85 mmHg

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Effects of Increasing Mean Arterial Pressure on Renal Function in Patients with Shock and with Elevated Central Venous Pressure : a Pilot Study for the Individualization of Mean Arterial Pressure
Actual Study Start Date : 2023-01-02
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Effects of Increasing Mean Arterial Pressure on Renal Function in Patients with Shock and with Elevated Central Venous Pressure

Location Details

NCT05655065

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Locations

RECRUITING

France,

Angers University Hospital

Angers, France,

RECRUITING

France,

Vendée Hospital

La Roche-sur-Yon, France,