Clinical trial NCT04281277: Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
Official title: Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: renal resistive index
mean arterial pressure
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates if improvement of renal resistive index when mean arterial pressure increase (at 65 mmHg to 85 mmHg) in early phase of septic shock is predictive of better renal survival.

Detailed description: Learned societes (survival sepsis campaign and ESICM) are currently recommending a mean arterial pressure (MAP) target at 65 mmHg in septic shoc with a potential increase to 85 mmHg in patients with medical history of arterial hypertension.

A high renal resistive index on the first day of septic shock was associated with acute renal failure more frequently on the 5th day. A decrease in the renal resistance index was also objectified during the increase in MAP.

The main objective of this trial is to study the relationship between the improvement of the resistance index during a test of increase in average blood pressure during septic shock and the improvement of renal function

In this interventional monocenter trial, we will measure the renal resistive index after stabilization of the MAP at 65 mmHg for two hours, then after 2 hours of stabilization at 85 mmHg. This part allows us to define the patients "responding" to the renal resistive index (improvement of the resitive renal index when the MAP increases).

Then, patients will be randomized into two groups :

* first group with a MAP target at 65 mmHg
* second group with a MAP target at 85 mmHg. There will be a stratification on the responder character to the renal resistance index.

Finally, we will assess renal function on the 7th day (with the assessment of serum creatinine and the change of stage of the KDIGO classification)

Eligibility criteria: Inclusion Criteria:

* adult patients (≥ 18 ans)
* Admitted to the intensive care unit of Angers with
* arterial hypotension requiring the etablishment of catecholamines
* In a context of proven or suspected sepsis, whaterver the cause of this infection.
* norepinephrine dose ⩾ 0.1µg/kg/min
* After 2 hours of stabilization at 65 mmHg of mean arterial pressure

Exclusion Criteria:

* Pre-existing chronic renal failure (glomerular filtration rate \< 60 mL/min with MDRD)
* Solitary kidney (anatomical or functional)
* History of united or bilateral stenosis of the renal arteries
* decision to stop or limit treatment
* 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 and oliguria/anuria \> 72 h.)
* 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

Primary outcomes:
measure: changes of KDIGO stage
timeFrame: Inclusion and day 7
Secondary outcomes:
measure: Renal resistive index
timeFrame: Inclusion, and 2 hours of mean arterial pressure stabilized at 85 mmHg and every day (day 1 to day 7)
measure: Collection of all adverse event
timeFrame: Day 1 to day 7
measure: amount of fluids (unit = L or L/day)
timeFrame: Inclusion, day 1 to day 7
measure: catecholamines free days
timeFrame: day 1 to day 7
measure: extra renal replacement free days
timeFrame: Daily to day 1 to day 7, at day 28 and day 90
measure: Number of day with supportive care in intensive care unit (renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)
timeFrame: Collection daily between Day 1 and Day 7, at Day 28.
measure: Number of day in intensive care unit
timeFrame: Collection at Day 28 and Day 90
measure: Number of day in hospital
timeFrame: Collection at Day 28 and Day 90
measure: hemodynamic data collected by swan ganz or PICCO catheter
timeFrame: Inclusion and at 2 hours, daily between Day 1 and Day 7
measure: quantity of nephrotoxic drugs
timeFrame: Inclusion and daily between Day 1 and Day 7.
measure: serum creatinine (unit = µmol/L)
timeFrame: Inclusion and daily between Day 1 and Day 7
measure: Diuresis (unit = mL per day)
timeFrame: Daily between day 1 and day 7
measure: Survival at day 28
timeFrame: patient status (live or dead) at day 28
measure: Survival at day 90
timeFrame: patient status (live or dead) at day 90
measure: Skin recoloration time evolution
timeFrame: Inclusion and at 2 hours, daily between Day 1 and Day 7
measure: Skin recoloration time evolution
timeFrame: Inclusion and at 2 hours, daily between Day 1 and Day 7
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers. Médecine Intensive Réanimation et médecine hyperbare
Study officials:
affiliation: University Hospital, Angers
name: Pierre ASFAR, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: