Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock (SEPSIR)

University Hospital, Angers

Status: Completed

Conditions: Septic Shock

Treatments: Device: increase of mean arterial pressure at 65-70 mmHg.; Device: increase of mean arterial pressure at 80-85 mmHg.

Study type: Interventional

Funder types: Other

Identifiers

NCT04281277

49RC19_0236

Details and patient eligibility

About

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.

Full 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)

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

low target group

Active Comparator group

Description:

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.

Treatment:

Device: increase of mean arterial pressure at 65-70 mmHg.

high target group

Experimental group

Description:

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.

Treatment:

Device: increase of mean arterial pressure at 80-85 mmHg.