ShockMAPAKINCT05655065
Effects of Increasing Mean Arterial Pressure on Renal Function in Patients With Shock and With Elevated Central Venous Pressure
A study testing increase of mean arterial pressure at 65-70 mmHg and increase of mean arterial pressure at 80-85 mmHg in people with Shock, run by University Hospital, Angers at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- increase of mean arterial pressure at 65-70 mmHg and increase of mean arterial pressure at 80-85 mmHg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ines ZIRIAT, MD contact
France2 sites, 2 recruiting
- Recruiting
Angers University Hospital
Angers
Pierre ASFAR, 02 41 35 58 65, PiAsfar@chu-angers.fr
- Recruiting
Vendée Hospital
La Roche-sur-Yon
Jean-Claude LACHERADE, 02 51 44 61 61, Jean-claude.lacherade@ght85.fr
About this study
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
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.
Read the 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.
- Conditions
- Shock
- Being tested
- increase of mean arterial pressure at 65-70 mmHg, increase of mean arterial pressure at 80-85 mmHg
- Keywords
- mean arterial pressure, central venous pressure, Renal function
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increase of mean arterial pressure at 65-70 mmHgProcedure or surgery
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 or surgery
Increase of mean arterial pressure at 80-85mmHg (with catecholamines or volemic expansion at the discretion of the clinician).
| Study group | Role | What they receive |
|---|---|---|
| Increase of MAP at low target 65-70 mmHg (with catecholamines or volemic expansion) | Active comparator | 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. Receives: Procedure: increase of mean arterial pressure at 65-70 mmHg |
| Increase of MAP at high target 80-85 mmHg (with catecholamines or volemic expansion) | Experimental | 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. Receives: Procedure: increase of mean arterial pressure at 80-85 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 hours and at 12 hours
Secondary outcomes (30)
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.
Measured: 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.
Measured: At inclusion.
Arterial hypertension treatment
We will report the anterior use of arterial hypertension treatment.
Measured: At inclusion.
Introduction time of norepinephrine
Day and hour of norepinephrine introduction.
Measured: At inclusion
Norepinephrine dose
Norepinephrine dose will be recorded every 2 hours during the two periods
Measured: At inclusion, then every hours up to hour 12
Amount of fluids (unit = L )
Amount of fluids received will be recorded at the end of each period.
Measured: At 6 hours and 12 hours
Quantity of nephrotoxic drugs
The quantity of nephrotoxic drugs administrated will be recorded.
Measured: At inclusion, at 6 hours and 12 hours
Intra-vesical pression
We will measure intra-vesical pression with the use of urinary catheter.
Measured: 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)
Measured: Day 90
Number of days in intensive care unit
Quantification of the number of days hospitalized in intensive care unit
Measured: Day 90
Number of days in hospital
Quantification of the number of days hospitalized
Measured: Day 90
Survival at day 90
Status alive or dead at day 90.
Measured: Day 90
Echocardiographic evaluation of left ventricular function
We will report visual estimation of left ventricular ejection fraction (in percent).
Measured: 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.
Measured: 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.
Measured: At inclusion, at 6 hours and at 12 hours.
Tidal volume
We will report the tidal volume set on the ventilator.
Measured: At inclusion, at 6 Horus and at 12 jours
Plateau pressure
We will report the plateau pressure (mmHg) measured on the ventilator.
Measured: At inclusion, at 6 hours and at 12 Hours.
End-expiratory pressure
We will report the end expiratory pressure (mmHg) measured on the ventilator.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At inclusion and every hour up to 12 hours
Troponin
Troponine dosage at the inclusion and the end of each period.
Measured: At inclusion, at 6 hours and at 12 hours.
Collection of all adverse event
We will collect all adverse event during the protocol.
Measured: At 6 hours and at 12 hours.
Ionogram
Results of ionogram will be recorded.
Measured: At inclusion, at 6 hours and at 12 hours.
paO2
paO2 measured on blood gases will be recorded (in mmHg).
Measured: At inclusion, at 6 hours and at 12 hours.
paCO2
paCO2 measured on blood gases will be recorded (in mmHg).
Measured: At inclusion, at 6 hours and at 12 hours.
Lactates
Lactates measured on blood gases will be recorded (in mmol/l).
Measured: At inclusion, at 6 hours and at 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start2 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ASFAR, MD PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655065
- Sponsor's protocol ID
- 49RC22_0293
- Acronym
- MAPAKI
- Status last verified
- Mar 2026
- First submitted
- 3 Nov 2022
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05655065
- Acronym / sponsor ID
- MAPAKI / 49RC22_0293
- Conditions
- Shock
- Keywords
- mean arterial pressure, central venous pressure, Renal function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increase of MAP at low target 65-70 mmHg (with catecholamines or volemic expansion) | Active comparator | Procedure: increase of mean arterial pressure at 65-70 mmHgTarget 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) | Experimental | Procedure: increase of mean arterial pressure at 80-85 mmHgTarget 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| increase of mean arterial pressure at 65-70 mmHgIncrease of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion at the discretion of the clinician) | Procedure or surgery | Increase of MAP at low target 65-70 mmHg (with catecholamines or volemic expansion) |
| increase of mean arterial pressure at 80-85 mmHgIncrease of mean arterial pressure at 80-85mmHg (with catecholamines or volemic expansion at the discretion of the clinician). | Procedure or surgery | Increase of MAP at high target 80-85 mmHg (with catecholamines or volemic expansion) |
Primary outcome
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
30 secondary outcomes
Changes of renal resistive index
Time frame: At 6 hours and 12 hours
Co-morbidities
Time frame: At inclusion.
Arterial hypertension treatment
Time frame: At inclusion.
Introduction time of norepinephrine
Time frame: At inclusion
Norepinephrine dose
Time frame: At inclusion, then every hours up to hour 12
Amount of fluids (unit = L )
Time frame: At 6 hours and 12 hours
Quantity of nephrotoxic drugs
Time frame: At inclusion, at 6 hours and 12 hours
Intra-vesical pression
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)
Time frame: Day 90
Number of days in intensive care unit
Time frame: Day 90
Number of days in hospital
Time frame: Day 90
Survival at day 90
Time frame: Day 90
Echocardiographic evaluation of left ventricular function
Time frame: At inclusion, at 6 hours et at 12 hours
Tricuspid annular plane systolic excursion (TAPSE)
Time frame: At inclusion, at 6 hours and at 12 hours.
Right S' wave
Time frame: At inclusion, at 6 hours and at 12 hours.
Tidal volume
Time frame: At inclusion, at 6 Horus and at 12 jours
Plateau pressure
Time frame: At inclusion, at 6 hours and at 12 Hours.
End-expiratory pressure
Time frame: At inclusion, at 6 hours and at 12 Hours.
Pulmonary compliance
Time frame: At inclusion, at 6 hours and at 12 Hours.
Cardiac index measured
Time frame: At inclusion and every hour up to 12 hours.
Continuous cardiac output
Time frame: At inclusion and every hour up to 12 hours
Pulmonary pressions
Time frame: At inclusion and every hour up to 12 hours
Extra vascular lung water
Time frame: At inclusion and every hour up to 12 hours
Pulmonary Vascular Permeability Indice
Time frame: At inclusion and every hour up to 12 hours
Troponin
Time frame: At inclusion, at 6 hours and at 12 hours.
Collection of all adverse event
Time frame: At 6 hours and at 12 hours.
Ionogram
Time frame: At inclusion, at 6 hours and at 12 hours.
paO2
Time frame: At inclusion, at 6 hours and at 12 hours.
paCO2
Time frame: At inclusion, at 6 hours and at 12 hours.
Lactates
Time frame: At inclusion, at 6 hours and at 12 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ines ZIRIAT, MD contact
Pierre ASFAR, MD PhD principal investigator
University Hospital, Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing increase of mean arterial pressure at 65-70 mmHg and increase of mean arterial pressure at 80-85 mmHg in people with Shock, run by University Hospital, Angers at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas FAGE, MD (+332 41 35 36 37, nicolas.fage@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of creatinine clearance (time frame: At 6 hours and at 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.