Assessment of the Hemodynamic Effect of Hydroxocabalamin in Refractory Vasodilatory Shock

NCT04964492 | Unknown

• 1 other identifier: PI2020_843_0124
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (HCB) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock). HCB produces beneficial alterations in NO metabolism and may be suitable in vasoplegic syndrome. In addition, HCB seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. By these different actions it would cause vasoconstriction in vascular smooth muscle cells. Previous reports demonstrate that HCB was useful for refractory vasoplegic syndrome. The investigators will conduct a retrospective data collection of patients who was given intravenous HCB for refractory vasoplegic shock since January 2019.

Conditions

Vasoplegia; Hemodynamics; Intensive Care Unit; Shock

Keywords

vasoplegia; hydroxocobalamin; hemodynamics; intensive care unit; shock

Outcome Measures

Primary Outcomes (1)

• Number of patients responding to treatment with HCB

  A patient will be defined as a responder to hydroxocobalamin infusion if there is an increase of more than 20% in average blood pressure, relative to the pre-treatment value, for at least 15 minutes within one hour of treatment administration.

  1 hour

Secondary Outcomes (4)

• The change in average blood pressure over time in responder patients

  one hour

• The change in average blood pressure over time in non-responder patients

  one hour

• The change in doses of NAd (mg/h) in responder patients

  one hour

• The change in doses of NAd (mg/h) in non-responder patients

  one hour

Study Arms (2)

responders to treatment

A patient will be defined as a responder to hydroxocobolamin infusion if there is an increase of more than 20% in Average blood pressure, relative to the pre-treatment value, for at least 15 minutes within one hour of treatment administration.

non-responders to treatment

A patient will be defined as a non-responder to hydroxocobolamin infusion if there is not an increase of more than 20% in Average blood pressure, relative to the pre-treatment value, for at least 15 minutes within one hour of treatment administration.

Eligibility Criteria

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

Study Population

All SVR (systemic vascular resistance) patients over 18 years of age who had received a dose of HCB since January 1 2019 will be included. Patients who received treatment for another indication were not included.

You may qualify if:

• All SVR patients over 18 years of age who had received a dose of HCB since January 1 2019 will be included.

You may not qualify if:

• Patients who received treatment for another indication were not included.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Vasoplegia; Shock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierre HUETTE, MD

CONTACT

03 22 08 78 99; huette.pierre@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 16, 2021
• Study Start: July 13, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)