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

Primary Purpose

Shock

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
increase of mean arterial pressure at 65-70 mmHg
increase of mean arterial pressure at 80-85 mmHg
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shock focused on measuring mean arterial pressure, central venous pressure, Renal function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

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

    Increase of MAP at high target 80-85 mmHg (with catecholamines or volemic expansion)

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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.
    Arterial hypertension treatment
    We will report the anterior use of arterial hypertension treatment.
    Introduction time of norepinephrine
    Day and hour of norepinephrine introduction.
    Norepinephrine dose
    Norepinephrine dose will be recorded every 2 hours during the two periods
    Amount of fluids (unit = L )
    Amount of fluids received will be recorded at the end of each period.
    Quantity of nephrotoxic drugs
    The quantity of nephrotoxic drugs administrated will be recorded.
    Intra-vesical pression
    We will measure intra-vesical pression with the use of urinary catheter.
    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)
    Number of days in intensive care unit
    Quantification of the number of days hospitalized in intensive care unit
    Number of days in hospital
    Quantification of the number of days hospitalized
    Survival at day 90
    Status alive or dead at day 90.
    Echocardiographic evaluation of left ventricular function
    We will report visual estimation of left ventricular ejection fraction (in percent).
    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.
    Right S' wave
    We will report the right S' wave (cm/s) measured on echocardiographic to evaluate the right ventricular function.
    Tidal volume
    We will report the tidal volume set on the ventilator.
    Plateau pressure
    We will report the plateau pressure (mmHg) measured on the ventilator.
    End-expiratory pressure
    We will report the end expiratory pressure (mmHg) measured on the ventilator.
    Pulmonary compliance
    The pulmonary compliance (in ml/mmHg) will be calculated using the formula : Pulmonary compliance = Tidal volume / (plateau pressure - end-expiratory pressure).
    Cardiac index measured
    We will record the cardiac index measured if the patient is monitored with a Swan Ganz catheter.
    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).
    Pulmonary pressions
    We will record the pulmonary arterial pressions if the patient is monitored with Swan Gan catheter.
    Extra vascular lung water
    We will record extra vascular lung water if the patient is monitored with PICCO.
    Pulmonary Vascular Permeability Indice
    We will record Pulmonary Vascular Permeability Indice if the patient is monitored with PICCO.
    Troponin
    Troponine dosage at the inclusion and the end of each period.
    Collection of all adverse event
    We will collect all adverse event during the protocol.
    Ionogram
    Results of ionogram will be recorded.
    paO2
    paO2 measured on blood gases will be recorded (in mmHg).
    paCO2
    paCO2 measured on blood gases will be recorded (in mmHg).
    Lactates
    Lactates measured on blood gases will be recorded (in mmol/l).

    Full Information

    First Posted
    November 3, 2022
    Last Updated
    December 14, 2022
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05655065
    Brief Title
    Effects of Increasing Mean Arterial Pressure on Renal Function in Patients With Shock and With Elevated Central Venous Pressure
    Acronym
    MAPAKI
    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

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    December 31, 2026 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shock
    Keywords
    mean arterial pressure, central venous pressure, Renal function

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Increase of MAP at low target 65-70 mmHg (with catecholamines or volemic expansion)
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Increase of MAP at high target 80-85 mmHg (with catecholamines or volemic expansion)
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    increase of mean arterial pressure at 65-70 mmHg
    Intervention Description
    Increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion at the discretion of the clinician)
    Intervention Type
    Procedure
    Intervention Name(s)
    increase of mean arterial pressure at 80-85 mmHg
    Intervention Description
    Increase of mean arterial pressure at 80-85mmHg (with catecholamines or volemic expansion at the discretion of the clinician).
    Primary Outcome Measure Information:
    Title
    Changes of creatinine clearance
    Description
    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 Outcome Measure Information:
    Title
    Changes of renal resistive index
    Description
    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
    Title
    Co-morbidities
    Description
    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.
    Title
    Arterial hypertension treatment
    Description
    We will report the anterior use of arterial hypertension treatment.
    Time Frame
    At inclusion.
    Title
    Introduction time of norepinephrine
    Description
    Day and hour of norepinephrine introduction.
    Time Frame
    At inclusion
    Title
    Norepinephrine dose
    Description
    Norepinephrine dose will be recorded every 2 hours during the two periods
    Time Frame
    At inclusion, then every hours up to hour 12
    Title
    Amount of fluids (unit = L )
    Description
    Amount of fluids received will be recorded at the end of each period.
    Time Frame
    At 6 hours and 12 hours
    Title
    Quantity of nephrotoxic drugs
    Description
    The quantity of nephrotoxic drugs administrated will be recorded.
    Time Frame
    At inclusion, at 6 hours and 12 hours
    Title
    Intra-vesical pression
    Description
    We will measure intra-vesical pression with the use of urinary catheter.
    Time Frame
    At inclusion then every hour up to 12 hours.
    Title
    Number of day with supportive care in intensive care unit (cathecolamines, renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)
    Description
    Quantification of the number of days with supportive care (catecholamine,renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)
    Time Frame
    Day 90
    Title
    Number of days in intensive care unit
    Description
    Quantification of the number of days hospitalized in intensive care unit
    Time Frame
    Day 90
    Title
    Number of days in hospital
    Description
    Quantification of the number of days hospitalized
    Time Frame
    Day 90
    Title
    Survival at day 90
    Description
    Status alive or dead at day 90.
    Time Frame
    Day 90
    Title
    Echocardiographic evaluation of left ventricular function
    Description
    We will report visual estimation of left ventricular ejection fraction (in percent).
    Time Frame
    At inclusion, at 6 hours et at 12 hours
    Title
    Tricuspid annular plane systolic excursion (TAPSE)
    Description
    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.
    Title
    Right S' wave
    Description
    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.
    Title
    Tidal volume
    Description
    We will report the tidal volume set on the ventilator.
    Time Frame
    At inclusion, at 6 Horus and at 12 jours
    Title
    Plateau pressure
    Description
    We will report the plateau pressure (mmHg) measured on the ventilator.
    Time Frame
    At inclusion, at 6 hours and at 12 Hours.
    Title
    End-expiratory pressure
    Description
    We will report the end expiratory pressure (mmHg) measured on the ventilator.
    Time Frame
    At inclusion, at 6 hours and at 12 Hours.
    Title
    Pulmonary compliance
    Description
    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.
    Title
    Cardiac index measured
    Description
    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.
    Title
    Continuous cardiac output
    Description
    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
    Title
    Pulmonary pressions
    Description
    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
    Title
    Extra vascular lung water
    Description
    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
    Title
    Pulmonary Vascular Permeability Indice
    Description
    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
    Title
    Troponin
    Description
    Troponine dosage at the inclusion and the end of each period.
    Time Frame
    At inclusion, at 6 hours and at 12 hours.
    Title
    Collection of all adverse event
    Description
    We will collect all adverse event during the protocol.
    Time Frame
    At 6 hours and at 12 hours.
    Title
    Ionogram
    Description
    Results of ionogram will be recorded.
    Time Frame
    At inclusion, at 6 hours and at 12 hours.
    Title
    paO2
    Description
    paO2 measured on blood gases will be recorded (in mmHg).
    Time Frame
    At inclusion, at 6 hours and at 12 hours.
    Title
    paCO2
    Description
    paCO2 measured on blood gases will be recorded (in mmHg).
    Time Frame
    At inclusion, at 6 hours and at 12 hours.
    Title
    Lactates
    Description
    Lactates measured on blood gases will be recorded (in mmol/l).
    Time Frame
    At inclusion, at 6 hours and at 12 hours.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicolas FAGE, MD
    Phone
    +332 41 35 36 37
    Email
    nicolas.fage@chu-angers.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ines ZIRIAT, MD
    Phone
    +332 41 35 36 37
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierre ASFAR, MD PhD
    Organizational Affiliation
    Angers University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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