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

ConditionShock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • increase of mean arterial pressure at 65-70 mmHg

    Procedure/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 mmHg

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Increase of MAP at low target 65-70 mmHg (with catecholamines or volemic expansion)Active comparator 1 intervention
Group B: Increase of MAP at high target 80-85 mmHg (with catecholamines or volemic expansion)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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.
3

Arterial hypertension treatment

We will report the anterior use of arterial hypertension treatment.

Time frame
At inclusion.
4

Introduction time of norepinephrine

Day and hour of norepinephrine introduction.

Time frame
At inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.