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

Primary Purpose

Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
increase of mean arterial pressure at 80-85 mmHg.
increase of mean arterial pressure at 65-70 mmHg.
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Septic Shock focused on measuring renal resistive index, mean arterial pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Angers. Médecine Intensive Réanimation et médecine hyperbareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

low target group

high target group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Collection of all adverse event
Difference in sides effects between target at 65-70 mmHg of MAP and 80-85 mmHg.
amount of fluids (unit = L or L/day)
catecholamines free days
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
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)
Number of day in intensive care unit
Quantification of the number of days hospitalized in intensive care unit
Number of day in hospital
Quantification of the number of days hospitalized.
hemodynamic data collected by swan ganz or PICCO catheter
quantity of nephrotoxic drugs
serum creatinine (unit = µmol/L)
Diuresis (unit = mL per day)
Survival at day 28
Survival at day 90

Full Information

First Posted
February 17, 2020
Last Updated
October 30, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04281277
Brief Title
Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
Acronym
SEPSIR
Official Title
Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2020 (Actual)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
March 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
renal resistive index, mean arterial pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low target group
Arm Type
Active Comparator
Arm 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.
Arm Title
high target group
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
increase of mean arterial pressure at 80-85 mmHg.
Intervention Description
increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).
Intervention Type
Device
Intervention Name(s)
increase of mean arterial pressure at 65-70 mmHg.
Intervention Description
increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).
Primary Outcome Measure Information:
Title
changes of KDIGO stage
Description
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)
Time Frame
Inclusion and day 7
Secondary Outcome Measure Information:
Title
Renal resistive index
Description
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
Time Frame
Inclusion, and 2 hours of mean arterial pressure stabilized at 85 mmHg and every day (day 1 to day 7)
Title
Collection of all adverse event
Description
Difference in sides effects between target at 65-70 mmHg of MAP and 80-85 mmHg.
Time Frame
Day 1 to day 7
Title
amount of fluids (unit = L or L/day)
Time Frame
Inclusion, day 1 to day 7
Title
catecholamines free days
Time Frame
day 1 to day 7
Title
extra renal replacement free days
Description
Difference in need of renal replacement therapy between the group of 80-85mmHg and the groupe 65-70 mmHg, depending on the responder character
Time Frame
Daily to day 1 to day 7, at day 28 and day 90
Title
Number of day with supportive care in intensive care unit (renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)
Description
Quantification of the number of days with supportive care (catecholamine,renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)
Time Frame
Collection daily between Day 1 and Day 7, at Day 28.
Title
Number of day in intensive care unit
Description
Quantification of the number of days hospitalized in intensive care unit
Time Frame
Collection at Day 28 and Day 90
Title
Number of day in hospital
Description
Quantification of the number of days hospitalized.
Time Frame
Collection at Day 28 and Day 90
Title
hemodynamic data collected by swan ganz or PICCO catheter
Time Frame
Inclusion and at 2 hours, daily between Day 1 and Day 7
Title
quantity of nephrotoxic drugs
Time Frame
Inclusion and daily between Day 1 and Day 7.
Title
serum creatinine (unit = µmol/L)
Time Frame
Inclusion and daily between Day 1 and Day 7
Title
Diuresis (unit = mL per day)
Time Frame
Daily between day 1 and day 7
Title
Survival at day 28
Time Frame
patient status (live or dead) at day 28
Title
Survival at day 90
Time Frame
patient status (live or dead) at day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas FAGE, Resident
Phone
0241355865
Email
fage.nicolas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre ASFAR, MD PHD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers. Médecine Intensive Réanimation et médecine hyperbare
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas FAGE, resident
Email
fage.nicolas@gmail.com
First Name & Middle Initial & Last Name & Degree
Pierre ASFAR, MD PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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