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NCT Number: NCT05655065

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

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.

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Key information

Conditions

Shock Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angers University Hospital, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

increase of mean arterial pressure at 65-70 mmHg

Procedure

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 mmHg

Procedure

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

Primary outcomes

  1. Changes of creatinine clearance

    Time frame: 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 outcomes

  1. Changes of renal resistive index

    Time frame: 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.

  2. Co-morbidities

    Time frame: 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.

  3. Arterial hypertension treatment

    Time frame: At inclusion.

    We will report the anterior use of arterial hypertension treatment.

  4. Introduction time of norepinephrine

    Time frame: At inclusion

    Day and hour of norepinephrine introduction.

  5. Norepinephrine dose

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

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

  6. Amount of fluids (unit = L )

    Time frame: At 6 hours and 12 hours

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

  7. Quantity of nephrotoxic drugs

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

    The quantity of nephrotoxic drugs administrated will be recorded.

  8. Intra-vesical pression

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

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

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

    Time frame: Day 90

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

  10. Number of days in intensive care unit

    Time frame: Day 90

    Quantification of the number of days hospitalized in intensive care unit

  11. Number of days in hospital

    Time frame: Day 90

    Quantification of the number of days hospitalized

  12. Survival at day 90

    Time frame: Day 90

    Status alive or dead at day 90.

  13. Echocardiographic evaluation of left ventricular function

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

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

  14. Tricuspid annular plane systolic excursion (TAPSE)

    Time frame: 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.

  15. Right S' wave

    Time frame: 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.

  16. Tidal volume

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

    We will report the tidal volume set on the ventilator.

  17. Plateau pressure

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

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

  18. End-expiratory pressure

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

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

  19. Pulmonary compliance

    Time frame: 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).

  20. Cardiac index measured

    Time frame: 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.

  21. Continuous cardiac output

    Time frame: 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).

  22. Pulmonary pressions

    Time frame: 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.

  23. Extra vascular lung water

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

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

  24. Pulmonary Vascular Permeability Indice

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

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

  25. Troponin

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

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

  26. Collection of all adverse event

    Time frame: At 6 hours and at 12 hours.

    We will collect all adverse event during the protocol.

  27. Ionogram

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

    Results of ionogram will be recorded.

  28. paO2

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

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

  29. paCO2

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

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

  30. Lactates

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ines ZIRIAT, MD

CONTACT

+332 41 35 36 37

Nicolas FAGE, MD

CONTACT

[email protected]

+332 41 35 36 37

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study 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

Acronym: MAPAKI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2022
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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