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

Shock Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05655065
• Other study ID #: 49RC22_0293
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2022
• Source: University Hospital, Angers
• Contact: Nicolas FAGE, MD
• Phone: +332 41 35 36 37
• Email: nicolas.fage[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock

Intervention

Procedure:
• increase 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)
• increase 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 6 hours and at 12 hours
Secondary	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.	At 6 hours and 12 hours
Secondary	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.	At inclusion.
Secondary	Arterial hypertension treatment	We will report the anterior use of arterial hypertension treatment.	At inclusion.
Secondary	Introduction time of norepinephrine	Day and hour of norepinephrine introduction.	At inclusion
Secondary	Norepinephrine dose	Norepinephrine dose will be recorded every 2 hours during the two periods	At inclusion, then every hours up to hour 12
Secondary	Amount of fluids (unit = L )	Amount of fluids received will be recorded at the end of each period.	At 6 hours and 12 hours
Secondary	Quantity of nephrotoxic drugs	The quantity of nephrotoxic drugs administrated will be recorded.	At inclusion, at 6 hours and 12 hours
Secondary	Intra-vesical pression	We will measure intra-vesical pression with the use of urinary catheter.	At inclusion then every hour up to 12 hours.
Secondary	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)	Day 90
Secondary	Number of days in intensive care unit	Quantification of the number of days hospitalized in intensive care unit	Day 90
Secondary	Number of days in hospital	Quantification of the number of days hospitalized	Day 90
Secondary	Survival at day 90	Status alive or dead at day 90.	Day 90
Secondary	Echocardiographic evaluation of left ventricular function	We will report visual estimation of left ventricular ejection fraction (in percent).	At inclusion, at 6 hours et at 12 hours
Secondary	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.	At inclusion, at 6 hours and at 12 hours.
Secondary	Right S' wave	We will report the right S' wave (cm/s) measured on echocardiographic to evaluate the right ventricular function.	At inclusion, at 6 hours and at 12 hours.
Secondary	Tidal volume	We will report the tidal volume set on the ventilator.	At inclusion, at 6 Horus and at 12 jours
Secondary	Plateau pressure	We will report the plateau pressure (mmHg) measured on the ventilator.	At inclusion, at 6 hours and at 12 Hours.
Secondary	End-expiratory pressure	We will report the end expiratory pressure (mmHg) measured on the ventilator.	At inclusion, at 6 hours and at 12 Hours.
Secondary	Pulmonary compliance	The pulmonary compliance (in ml/mmHg) will be calculated using the formula : Pulmonary compliance = Tidal volume / (plateau pressure - end-expiratory pressure).	At inclusion, at 6 hours and at 12 Hours.
Secondary	Cardiac index measured	We will record the cardiac index measured if the patient is monitored with a Swan Ganz catheter.	At inclusion and every hour up to 12 hours.
Secondary	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).	At inclusion and every hour up to 12 hours
Secondary	Pulmonary pressions	We will record the pulmonary arterial pressions if the patient is monitored with Swan Gan catheter.	At inclusion and every hour up to 12 hours
Secondary	Extra vascular lung water	We will record extra vascular lung water if the patient is monitored with PICCO.	At inclusion and every hour up to 12 hours
Secondary	Pulmonary Vascular Permeability Indice	We will record Pulmonary Vascular Permeability Indice if the patient is monitored with PICCO.	At inclusion and every hour up to 12 hours
Secondary	Troponin	Troponine dosage at the inclusion and the end of each period.	At inclusion, at 6 hours and at 12 hours.
Secondary	Collection of all adverse event	We will collect all adverse event during the protocol.	At 6 hours and at 12 hours.
Secondary	Ionogram	Results of ionogram will be recorded.	At inclusion, at 6 hours and at 12 hours.
Secondary	paO2	paO2 measured on blood gases will be recorded (in mmHg).	At inclusion, at 6 hours and at 12 hours.
Secondary	paCO2	paCO2 measured on blood gases will be recorded (in mmHg).	At inclusion, at 6 hours and at 12 hours.
Secondary	Lactates	Lactates measured on blood gases will be recorded (in mmol/l).	At inclusion, at 6 hours and at 12 hours.