NCT06072508

Brief Summary

In septic shock, the intensity and duration of low blood pressure can lead to a critical reduction in renal tissue perfusion and lead to the onset of more or less severe Acute Kidney Injury (AKI). Vasorin (Vasn) is a protein strongly expressed in large vessels and kidneys, whose functions are still poorly known. Previous experimental studies show that Vasn is associated with decreased Angiotensin II concentrations, a vessel contractility defect and early mortality. The investigators hypothesize that Vasn (the potential direct regulator of blood pressure) would be an early biomarker predicting the severity of AKI post septic shock, which may be associated with mortality from septic shock or lead to longer-term Chronic Renal Failure (CKD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

October 3, 2023

Last Update Submit

March 26, 2026

Conditions

Keywords

vasorinSepsisangiotensin IIAcute Kidney Injury

Outcome Measures

Primary Outcomes (2)

  • correlation between vasorin concentration at day 0 and mortality rate

    day 0

  • correlation between vasorin concentration at day 3 and mortality rate

    day 3

Interventions

Blood samplingBIOLOGICAL

Blood sampling (at day 0 and day 3) for Vasn, Angiotensin 2 and clotting markers.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years old.
  • Hospitalized in intensive care or medical resuscitation units.
  • With a septic shock state defined by 2 mmol/l lactate sepsis, requiring vasopressors to maintain mean blood pressure 65 mmHg (despite adequate vascular filling).
  • Whether or not they have developed AKI.
  • Patient/family information and collection of non opposition

You may not qualify if:

  • Patients with chronic respiratory failure.
  • Pregnant women.
  • Patients in palliative care.
  • Information for the patient/someone close and collection of his opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80000, France

Location

MeSH Terms

Conditions

SepsisAcute Kidney Injury

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 10, 2023

Study Start

July 3, 2023

Primary Completion

March 29, 2025

Study Completion

March 29, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations