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

University Hospital, Angers

Status: Enrolling

Conditions: Shock

Treatments: Procedure: increase of mean arterial pressure at 65-70 mmHg; Procedure: increase of mean arterial pressure at 80-85 mmHg

Study type: Interventional

Funder types: Other

Identifiers

NCT05655065

49RC22_0293

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

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

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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