An interventional study of increase of mean arterial pressure at 65-70 mmHg and increase of mean arterial pressure at 80-85 mmHg in Shock, sponsored by University Hospital, Angers. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Other
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
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.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 229 interventional studies indexed under Shock.
Browse Shock studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
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Exclusion Criteria:
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.
Procedure: increase of mean arterial pressure at 65-70 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.
Procedure: increase of mean arterial pressure at 80-85 mmHg
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 80-85mmHg (with catecholamines or volemic expansion at the discretion of the clinician).
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
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
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.
Started Jan 2023 (actual). Primary completion is estimated for Dec 2026, 47 months after the start.
Of 67 non-industry interventional studies with no phase under Shock, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 47 months is above that.
Counting every sponsor, half of 70 studies reached it within 25 months; a quarter within 8 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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