Shock
Conditions
Keywords
mean arterial pressure, central venous pressure, Renal function
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.
Interventions
PROCEDUREincrease of mean arterial pressure at 65-70 mmHg
Increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion at the discretion of the clinician)
PROCEDUREincrease of mean arterial pressure at 80-85 mmHg
Increase of mean arterial pressure at 80-85mmHg (with catecholamines or volemic expansion at the discretion of the clinician).
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
| Intra-vesical pression | At inclusion then every hour up to 12 hours. | 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) | Day 90 | 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 | Day 90 | Quantification of the number of days hospitalized in intensive care unit |
| Number of days in hospital | Day 90 | Quantification of the number of days hospitalized |
| Survival at day 90 | Day 90 | Status alive or dead at day 90. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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). |
| 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. |
| 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. |
| Collection of all adverse event | At 6 hours and at 12 hours. | We will collect all adverse event during the protocol. |
| Ionogram | At inclusion, at 6 hours and at 12 hours. | Results of ionogram will be recorded. |
| paO2 | At inclusion, at 6 hours and at 12 hours. | paO2 measured on blood gases will be recorded (in mmHg). |
| paCO2 | At inclusion, at 6 hours and at 12 hours. | paCO2 measured on blood gases will be recorded (in mmHg). |
| Lactates | At inclusion, at 6 hours and at 12 hours. | Lactates measured on blood gases will be recorded (in mmol/l). |
Countries
France
Contacts
CONTACTNicolas FAGE, MD
CONTACTInes ZIRIAT, MD
PRINCIPAL_INVESTIGATORPierre ASFAR, MD PhD
Angers University Hospital
Outcome results
None listed