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

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Device: increase of mean arterial pressure at 65-70 mmHg.; Device: increase of mean arterial pressure at 80-85 mmHg.

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)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas FAGE, Resident; Phone Number: 0241355865; Email: fage.nicolas@gmail.com

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • CHU Angers. Médecine Intensive Réanimation et médecine hyperbare
    • Contact: Nicolas FAGE, resident; Email: fage.nicolas@gmail.com
    • Principal Investigator: Pierre ASFAR, MD PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: low target group; 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.	Device: increase of mean arterial pressure at 65-70 mmHg.; increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).
Experimental: high target group; 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.	Device: increase of mean arterial pressure at 80-85 mmHg.; increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of KDIGO stage	modification of the KDIGO classification stage (estimated based on serum creatinine and diuresis) between the group with low target of mean arterial pressure ( 65-70 mmHg) and high target MAP (80-85 mmHg)	Inclusion and day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal resistive index	We will assess the evolution of the renal resistive index during an increase in the target of MAP in the early phase of septic shock . We will assess the evolution of renal resistive index according to the comorbidities, as a function of time in septic shock, according to the hemodynamic data, according to quantity of filling solution administered and catecholamine doses	Inclusion, and 2 hours of mean arterial pressure stabilized at 85 mmHg and every day (day 1 to day 7)
Collection of all adverse event	Difference in sides effects between target at 65-70 mmHg of MAP and 80-85 mmHg.	Day 1 to day 7
amount of fluids (unit = L or L/day)		Inclusion, day 1 to day 7
catecholamines free days		day 1 to day 7
extra renal replacement free days	Difference in need of renal replacement therapy between the group of 80-85mmHg and the groupe 65-70 mmHg, depending on the responder character	Daily to day 1 to day 7, at day 28 and day 90
Number of day with supportive care in intensive care unit (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)	Collection daily between Day 1 and Day 7, at Day 28.
Number of day in intensive care unit	Quantification of the number of days hospitalized in intensive care unit	Collection at Day 28 and Day 90
Number of day in hospital	Quantification of the number of days hospitalized.	Collection at Day 28 and Day 90
hemodynamic data collected by swan ganz or PICCO catheter		Inclusion and at 2 hours, daily between Day 1 and Day 7
quantity of nephrotoxic drugs		Inclusion and daily between Day 1 and Day 7.
serum creatinine (unit = µmol/L)		Inclusion and daily between Day 1 and Day 7
Diuresis (unit = mL per day)		Daily between day 1 and day 7
Survival at day 28		patient status (live or dead) at day 28
Survival at day 90		patient status (live or dead) at day 90

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Pierre ASFAR, MD PHD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2020
• Primary Completion (Anticipated): January 15, 2025
• Study Completion (Anticipated): March 15, 2026

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 30, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: mean arterial pressure; renal resistive index
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 49RC19_0236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No