Effects of Increasing Mean Arterial Pressure on Renal Function in Patients with Shock and with Elevated Central Venous Pressure
- Conditions
- Shock
- Interventions
- Procedure: increase of mean arterial pressure at 65-70 mmHgProcedure: increase of mean arterial pressure at 80-85 mmHg
- Registration Number
- NCT05655065
- Lead 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Increase of MAP at low target 65-70 mmHg (with catecholamines or volemic expansion) increase of mean arterial pressure at 65-70 mmHg 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. Increase of MAP at high target 80-85 mmHg (with catecholamines or volemic expansion) increase of mean arterial pressure at 80-85 mmHg 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.
- Primary Outcome Measures
Name Time Method Changes of creatinine clearance At 6 hours and at 12 hours 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
- Secondary Outcome Measures
Name Time Method Arterial hypertension treatment At inclusion. We will report the anterior use of arterial hypertension treatment.
Introduction time of norepinephrine At inclusion Day and hour of norepinephrine introduction.
Norepinephrine dose At inclusion, then every hours up to hour 12 Norepinephrine dose will be recorded every 2 hours during the two periods
Number of days in intensive care unit Day 90 Quantification of the number of days hospitalized in intensive care unit
Survival at day 90 Day 90 Status alive or dead at day 90.
Co-morbidities At inclusion. 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.
Intra-vesical pression At inclusion then every hour up to 12 hours. We will measure intra-vesical pression with the use of urinary catheter.
Pulmonary compliance At inclusion, at 6 hours and at 12 Hours. The pulmonary compliance (in ml/mmHg) will be calculated using the formula : Pulmonary compliance = Tidal volume / (plateau pressure - end-expiratory pressure).
Changes of renal resistive index At 6 hours and 12 hours 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.Amount of fluids (unit = L ) At 6 hours and 12 hours Amount of fluids received will be recorded at the end of each period.
Quantity of nephrotoxic drugs At inclusion, at 6 hours and 12 hours The quantity of nephrotoxic drugs administrated will be recorded.
Number of day with supportive care in intensive care unit (cathecolamines, renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation) Day 90 Quantification of the number of days with supportive care (catecholamine,renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)
Number of days in hospital Day 90 Quantification of the number of days hospitalized
Tricuspid annular plane systolic excursion (TAPSE) At inclusion, at 6 hours and at 12 hours. We will report the tricuspid annular plane systolic excursion (mm) measured on echocardiographic to evaluate the right ventricular function.
Plateau pressure At inclusion, at 6 hours and at 12 Hours. We will report the plateau pressure (mmHg) measured on the ventilator.
End-expiratory pressure At inclusion, at 6 hours and at 12 Hours. We will report the end expiratory pressure (mmHg) measured on the ventilator.
paCO2 At inclusion, at 6 hours and at 12 hours. paCO2 measured on blood gases will be recorded (in mmHg).
Echocardiographic evaluation of left ventricular function At inclusion, at 6 hours et at 12 hours We will report visual estimation of left ventricular ejection fraction (in percent).
Cardiac index measured At inclusion and every hour up to 12 hours. We will record the cardiac index measured if the patient is monitored with a Swan Ganz catheter.
Right S' wave At inclusion, at 6 hours and at 12 hours. We will report the right S' wave (cm/s) measured on echocardiographic to evaluate the right ventricular function.
Tidal volume At inclusion, at 6 Horus and at 12 jours We will report the tidal volume set on the ventilator.
Pulmonary pressions At inclusion and every hour up to 12 hours We will record the pulmonary arterial pressions if the patient is monitored with Swan Gan catheter.
Collection of all adverse event At 6 hours and at 12 hours. We will collect all adverse event during the protocol.
paO2 At inclusion, at 6 hours and at 12 hours. paO2 measured on blood gases will be recorded (in mmHg).
Continuous cardiac output At inclusion and every hour up to 12 hours 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).
Extra vascular lung water At inclusion and every hour up to 12 hours We will record extra vascular lung water if the patient is monitored with PICCO.
Pulmonary Vascular Permeability Indice At inclusion and every hour up to 12 hours We will record Pulmonary Vascular Permeability Indice if the patient is monitored with PICCO.
Troponin At inclusion, at 6 hours and at 12 hours. Troponine dosage at the inclusion and the end of each period.
Ionogram At inclusion, at 6 hours and at 12 hours. Results of ionogram will be recorded.
Lactates At inclusion, at 6 hours and at 12 hours. Lactates measured on blood gases will be recorded (in mmol/l).
Trial Locations
- Locations (2)
Angers University Hospital
🇫🇷Angers, France
Vendée Hospital
🇫🇷La Roche Sur Yon, France