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

NCT04281277 | Completed DMC

• 1 other identifier: 49RC19_0236
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

renal resistive index; mean arterial pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Renal resistive index

  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

  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

  Daily to day 1 to day 7, at day 28 and day 90

Study Arms (2)

low target group

ACTIVE COMPARATOR

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.

high target group

EXPERIMENTAL

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.

Interventions

increase of mean arterial pressure at 80-85 mmHg. DEVICE

increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).

high target group

increase of mean arterial pressure at 65-70 mmHg. DEVICE

increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).

low target group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers. Médecine Intensive Réanimation et médecine hyperbare

Angers, 49100, France

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Pierre ASFAR, MD PHD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 24, 2020
• Study Start: June 6, 2020
• Primary Completion: October 29, 2024
• Study Completion: February 4, 2025
• Last Updated: March 6, 2026

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
• Access Criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).

Locations

FR (1)