Septic ShockSEPSIRNCT04281277

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

A study testing increase of mean arterial pressure at 80-85 mmHg. and increase of mean arterial pressure at 65-70 mmHg. in people with Septic Shock, run by University Hospital, Angers at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Septic Shock
What is being tested?: increase of mean arterial pressure at 80-85 mmHg. and increase of mean arterial pressure at 65-70 mmHg.
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteFrance
Study dates: 6 Jun 2020to 4 Feb 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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patient deprived of liberty by judicial or administrative decision
patient with psychiatric compulsory care
patient subject to legal protection measures

Trial locations and contacts

1 site in 1 country.

France1 site

CHU Angers. Médecine Intensive Réanimation et médecine hyperbare
Angers, 49100

Other trials in France

About this study

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.

Read the 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)

Conditions: Septic Shock
Being tested: increase of mean arterial pressure at 80-85 mmHg., increase of mean arterial pressure at 65-70 mmHg.
Keywords: renal resistive index, mean arterial pressure
Medical subject headings: Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

increase of mean arterial pressure at 80-85 mmHg.Device
increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).
increase of mean arterial pressure at 65-70 mmHg.Device
increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).

Study groups in NCT04281277
Study group	Role	What they receive
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. Receives: 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. Receives: Device: increase of mean arterial pressure at 80-85 mmHg.

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Inclusion and day 7

Secondary outcomes (16)

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
Measured: 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.
Measured: Day 1 to day 7
amount of fluids (unit = L or L/day)
Measured: Inclusion, day 1 to day 7
catecholamines free days
Measured: 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
Measured: 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)
Measured: 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
Measured: Collection at Day 28 and Day 90
Number of day in hospital
Quantification of the number of days hospitalized.
Measured: Collection at Day 28 and Day 90
hemodynamic data collected by swan ganz or PICCO catheter
Measured: Inclusion and at 2 hours, daily between Day 1 and Day 7
quantity of nephrotoxic drugs
Measured: Inclusion and daily between Day 1 and Day 7.
serum creatinine (unit = µmol/L)
Measured: Inclusion and daily between Day 1 and Day 7
Diuresis (unit = mL per day)
Measured: Daily between day 1 and day 7
Survival at day 28
Measured: patient status (live or dead) at day 28
Survival at day 90
Measured: patient status (live or dead) at day 90
Skin recoloration time evolution
measurement onto the right index finger by a standardized method after 2 hours of stabilization at 65 mmHg and after 2 hours of stabilization at 85 mmHg.
Measured: Inclusion and at 2 hours, daily between Day 1 and Day 7
Skin recoloration time evolution
measurement onto the right index fingerby a standardized method depending on the randomization group.
Measured: Inclusion and at 2 hours, daily between Day 1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 20204 Feb 2025

First posted24 Feb 2020
Study start6 Jun 2020
Primary completion29 Oct 2024
Study completion4 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Septic ShockStudies of the same condition, open and under way.
More trials run by University Hospital, AngersThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04281277
Sponsor's protocol ID: 49RC19_0236
Acronym: SEPSIR
Status last verified: Oct 2022
First submitted: 17 Feb 2020
Last updated: 6 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.

Publications

Fage N, Bouizegarene M, Seegers V, Courtais A, Bordeau L, Ziriat I, Mercat A, Beloncle F, Lerolle N, Radermacher P, Demiselle J, Asfar P. Renal Resistive Index Responsiveness to a Mean Arterial Pressure Test As a Guide for Mean Arterial Pressure Target in the Early Phase of Septic Shock: A Physiological Study. Crit Care Med. 2026 Oct 1;54(10):2613-2624. doi: 10.1097/CCM.0000000000007286. Epub 2026 Aug 3.
PubMed 42545101

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis

All Septic Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
ClinicalTrials.gov ID: NCT04281277
Acronym / sponsor ID: SEPSIR / 49RC19_0236
Conditions: Septic Shock
Keywords: renal resistive index, mean arterial pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: University Hospital, AngersOther government
Study start: 6 Jun 2020 (actual)
Primary completion: 29 Oct 2024 (actual)
Study completion: 4 Feb 2025 (actual)
First posted: 24 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
low target group	Active comparator	Device: increase of mean arterial pressure at 65-70 mmHg.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.
high target group	Experimental	Device: increase of mean arterial pressure at 80-85 mmHg.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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
increase of mean arterial pressure at 80-85 mmHg.increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).	Device	high target group
increase of mean arterial pressure at 65-70 mmHg.increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).	Device	low target group

Primary outcome

changes of KDIGO stage
Time frame: Inclusion and day 7
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)

16 secondary outcomes

Renal resistive index
Time frame: 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
Time frame: Day 1 to day 7
amount of fluids (unit = L or L/day)
Time frame: Inclusion, day 1 to day 7
catecholamines free days
Time frame: day 1 to day 7
extra renal replacement free days
Time frame: 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)
Time frame: Collection daily between Day 1 and Day 7, at Day 28.
Number of day in intensive care unit
Time frame: Collection at Day 28 and Day 90
Number of day in hospital
Time frame: Collection at Day 28 and Day 90
hemodynamic data collected by swan ganz or PICCO catheter
Time frame: Inclusion and at 2 hours, daily between Day 1 and Day 7
quantity of nephrotoxic drugs
Time frame: Inclusion and daily between Day 1 and Day 7.
serum creatinine (unit = µmol/L)
Time frame: Inclusion and daily between Day 1 and Day 7
Diuresis (unit = mL per day)
Time frame: Daily between day 1 and day 7
Survival at day 28
Time frame: patient status (live or dead) at day 28
Survival at day 90
Time frame: patient status (live or dead) at day 90
Skin recoloration time evolution
Time frame: Inclusion and at 2 hours, daily between Day 1 and Day 7
Skin recoloration time evolution
Time frame: Inclusion and at 2 hours, daily between Day 1 and Day 7

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
Derived from this study: PubMed 42545101Fage N, Bouizegarene M, Seegers V, Courtais A, Bordeau L, Ziriat I, Mercat A, Beloncle F, Lerolle N, Radermacher P, Demiselle J, Asfar P. Renal Resistive Index Responsiveness to a Mean Arterial Pressure Test As a Guide for Mean Arterial Pressure Target in the Early Phase of Septic Shock: A Physiological Study. Crit Care Med. 2026 Oct 1;54(10):2613-2624. doi: 10.1097/CCM.0000000000007286. Epub 2026 Aug 3.
Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.

Related trials for Septic Shock

Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pierre ASFAR, MD PHD principal investigator

University Hospital, Angers

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes of KDIGO stage (time frame: Inclusion and day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04281277, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.