VASO-SHOCK: Prognostic Interest of Vasorin in Septic Shock

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06072508
• Collaborator: Centre Hospitalier Abbeville (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 19.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Acute Kidney Injury	Biological: Blood sampling	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Prognostic Interest of Vasorin in Septic Shock
• Actual Study Start Date: Jul 3, 2023
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Outcome Measures

Primary Outcome Measures

1. correlation between vasorin concentration at day 0 and mortality rate [day 0]

2. correlation between vasorin concentration at day 3 and mortality rate [day 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with chronic respiratory failure.

• Pregnant women.

• Patients in palliative care.

• Information for the patient/someone close and collection of his opposition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens-Picardie	Amiens		France	80000

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens
• Centre Hospitalier Abbeville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT06072508
• Other Study ID Numbers: PI2023_843_0073
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire, Amiens: vasorin; Sepsis; angiotensin II; Acute Kidney Injury
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Oct 10, 2023