NCT06160219

Prophylactic Use of Hydroxycobolamin in Vasoplegic Syndrome in Adult Patients Undergoing Cardiopulmonary Bypass

Completed Phase 2, PHASE3 Last updated 12 June 2024

What this trial tests

Phase 2, PHASE3 trial testing Hydroxycobalamin in Vasoplegic Syndrome in 60 participants. Completed in 27 November 2023.

Timeline

28 August 2019

Primary endpoint
20 November 2023

27 November 2023

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	28 August 2019
Primary completion	20 November 2023
Estimated completion	27 November 2023
Sites	1 location across Egypt

Drugs / interventions tested

• Hydroxycobalamin — full drug profile →

Conditions studied

• Vasoplegic Syndrome — all drugs for Vasoplegic Syndrome →

Sponsor

Ain Shams University

Who can join

Adults 18 to 60, any sex, with Vasoplegic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Several studies have described the use of alternative drugs as methylene blue (MB) (3) other than the standard limited options of the use of vasopressors and systemic corticosteroids (4) especially in the face of increasing incidence of vasoplegic syndrome. Hydroxycobolamin (HCO) has been used for treating cyanide poisoning for more than 40 years. Persistant and significant hypertension occurred as a result of the ability of (HCO) to bind nitric oxide (NO) to form nitrocobalamin.

In this prospective randomized controlled trial, we hypothesized that the prophylactic use of HCO in high risk patients after CPB may decrease the incidence of vasoplegia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.