Clinical trial NCT05655065: Effects of Increasing Mean Arterial Pressure on Renal Function in Patients with Shock and with Elevated Central Venous Pressure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shock
Keywords: mean arterial pressure
central venous pressure
Renal function
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Changes of creatinine clearance
timeFrame: At 6 hours and at 12 hours
Secondary outcomes:
measure: Changes of renal resistive index
timeFrame: At 6 hours and 12 hours
measure: Co-morbidities
timeFrame: At inclusion.
measure: Arterial hypertension treatment
timeFrame: At inclusion.
measure: Introduction time of norepinephrine
timeFrame: At inclusion
measure: Norepinephrine dose
timeFrame: At inclusion, then every hours up to hour 12
measure: Amount of fluids (unit = L )
timeFrame: At 6 hours and 12 hours
measure: Quantity of nephrotoxic drugs
timeFrame: At inclusion, at 6 hours and 12 hours
measure: Intra-vesical pression
timeFrame: At inclusion then every hour up to 12 hours.
measure: Number of day with supportive care in intensive care unit (cathecolamines, renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)
timeFrame: Day 90
measure: Number of days in intensive care unit
timeFrame: Day 90
measure: Number of days in hospital
timeFrame: Day 90
measure: Survival at day 90
timeFrame: Day 90
measure: Echocardiographic evaluation of left ventricular function
timeFrame: At inclusion, at 6 hours et at 12 hours
measure: Tricuspid annular plane systolic excursion (TAPSE)
timeFrame: At inclusion, at 6 hours and at 12 hours.
measure: Right S' wave
timeFrame: At inclusion, at 6 hours and at 12 hours.
measure: Tidal volume
timeFrame: At inclusion, at 6 Horus and at 12 jours
measure: Plateau pressure
timeFrame: At inclusion, at 6 hours and at 12 Hours.
measure: End-expiratory pressure
timeFrame: At inclusion, at 6 hours and at 12 Hours.
measure: Pulmonary compliance
timeFrame: At inclusion, at 6 hours and at 12 Hours.
measure: Cardiac index measured
timeFrame: At inclusion and every hour up to 12 hours.
measure: Continuous cardiac output
timeFrame: At inclusion and every hour up to 12 hours
measure: Pulmonary pressions
timeFrame: At inclusion and every hour up to 12 hours
measure: Extra vascular lung water
timeFrame: At inclusion and every hour up to 12 hours
measure: Pulmonary Vascular Permeability Indice
timeFrame: At inclusion and every hour up to 12 hours
measure: Troponin
timeFrame: At inclusion, at 6 hours and at 12 hours.
measure: Collection of all adverse event
timeFrame: At 6 hours and at 12 hours.
measure: Ionogram
timeFrame: At inclusion, at 6 hours and at 12 hours.
measure: paO2
timeFrame: At inclusion, at 6 hours and at 12 hours.
measure: paCO2
timeFrame: At inclusion, at 6 hours and at 12 hours.
measure: Lactates
timeFrame: At inclusion, at 6 hours and at 12 hours.
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: La Roche Sur Yon
country: France
facility: Vendée Hospital
Study officials:
affiliation: Angers University Hospital
name: Pierre ASFAR, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: