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

University Hospital, Angers30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Shock

Interventions

increase of mean arterial pressure at 65-70 mmHgPROCEDURE

Increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion at the discretion of the clinician)

increase of mean arterial pressure at 80-85 mmHgPROCEDURE

Increase of mean arterial pressure at 80-85mmHg (with catecholamines or volemic expansion at the discretion of the clinician).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Angers University Hospital

Angers, France

RECRUITING

Vendée Hospital

La Roche-sur-Yon, France

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: At 6 hours and at 12 hours

Secondary Outcomes

Changes of renal resistive index

We will assess the changes of the renal resistive index with a low MAP target (65-70mmHg) and with a high MAP target (80-85mmHg). Renal resistive index is measured with the use of doppler sonography and is calculated as follow : (peak systolic velocity - end diastolic velocity / peak systolic velocity) Renal resistive index from 3 waveforms are averaged to arrive at mean RI values for each kidney.

Time frame: At 6 hours and 12 hours

Co-morbidities

We will report rate of pre-existing conditions : ischemic heart disease, chronic heart failure, chronic obstructive pulmonary disease, chronic kidney disease, chronic kidney disease requiring long-term dialysis, liver cirrhosis, diabetes, cancer or autoimmune disease, chronic arterial hypertension.

Time frame: At inclusion.

Arterial hypertension treatment

We will report the anterior use of arterial hypertension treatment.

Time frame: At inclusion.

Introduction time of norepinephrine

Day and hour of norepinephrine introduction.

Time frame: At inclusion

Norepinephrine dose

Norepinephrine dose will be recorded every 2 hours during the two periods

Time frame: At inclusion, then every hours up to hour 12

Central Contacts

Nicolas FAGE, MD

CONTACT

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

Ines ZIRIAT, MD

CONTACT

+332 41 35 36 37

Data from ClinicalTrials.gov

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Amount of fluids (unit = L )

Amount of fluids received will be recorded at the end of each period.

Time frame: At 6 hours and 12 hours

Quantity of nephrotoxic drugs

The quantity of nephrotoxic drugs administrated will be recorded.

Time frame: At inclusion, at 6 hours and 12 hours

Intra-vesical pression

We will measure intra-vesical pression with the use of urinary catheter.

Time frame: At inclusion then every hour up to 12 hours.

Number of day with supportive care in intensive care unit (cathecolamines, renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)

Quantification of the number of days with supportive care (catecholamine,renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)

Time frame: Day 90

Number of days in intensive care unit

Quantification of the number of days hospitalized in intensive care unit

Time frame: Day 90

Number of days in hospital

Quantification of the number of days hospitalized

Time frame: Day 90

Survival at day 90

Status alive or dead at day 90.

Time frame: Day 90

Echocardiographic evaluation of left ventricular function

We will report visual estimation of left ventricular ejection fraction (in percent).

Time frame: At inclusion, at 6 hours et at 12 hours

Tricuspid annular plane systolic excursion (TAPSE)

We will report the tricuspid annular plane systolic excursion (mm) measured on echocardiographic to evaluate the right ventricular function.

Time frame: At inclusion, at 6 hours and at 12 hours.

Right S' wave

We will report the right S' wave (cm/s) measured on echocardiographic to evaluate the right ventricular function.

Time frame: At inclusion, at 6 hours and at 12 hours.

Tidal volume

We will report the tidal volume set on the ventilator.

Time frame: At inclusion, at 6 Horus and at 12 jours

Plateau pressure

We will report the plateau pressure (mmHg) measured on the ventilator.

Time frame: At inclusion, at 6 hours and at 12 Hours.

End-expiratory pressure

We will report the end expiratory pressure (mmHg) measured on the ventilator.

Time frame: At inclusion, at 6 hours and at 12 Hours.

Pulmonary compliance

The pulmonary compliance (in ml/mmHg) will be calculated using the formula : Pulmonary compliance = Tidal volume / (plateau pressure - end-expiratory pressure).

Time frame: At inclusion, at 6 hours and at 12 Hours.

Cardiac index measured

We will record the cardiac index measured if the patient is monitored with a Swan Ganz catheter.

Time frame: At inclusion and every hour up to 12 hours.

Continuous cardiac output

We will record continuous cardiac output monitoring on pulse contour analysis of the invasive arterial blood pressure curve if the patient is monitored with Pulse index Continuous Cardiac Output (PICCO).

Time frame: At inclusion and every hour up to 12 hours

Pulmonary pressions

We will record the pulmonary arterial pressions if the patient is monitored with Swan Gan catheter.

Time frame: At inclusion and every hour up to 12 hours

Extra vascular lung water

We will record extra vascular lung water if the patient is monitored with PICCO.

Time frame: At inclusion and every hour up to 12 hours

Pulmonary Vascular Permeability Indice

We will record Pulmonary Vascular Permeability Indice if the patient is monitored with PICCO.

Time frame: At inclusion and every hour up to 12 hours

Troponin

Troponine dosage at the inclusion and the end of each period.

Time frame: At inclusion, at 6 hours and at 12 hours.

Collection of all adverse event

We will collect all adverse event during the protocol.

Time frame: At 6 hours and at 12 hours.

Ionogram

Results of ionogram will be recorded.

Time frame: At inclusion, at 6 hours and at 12 hours.

paO2

paO2 measured on blood gases will be recorded (in mmHg).

Time frame: At inclusion, at 6 hours and at 12 hours.

paCO2

paCO2 measured on blood gases will be recorded (in mmHg).

Time frame: At inclusion, at 6 hours and at 12 hours.

Lactates

Lactates measured on blood gases will be recorded (in mmol/l).

Time frame: At inclusion, at 6 hours and at 12 hours.