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

• Status: Completed
• Trial end date: 2023-11-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Hydroxocobalamin; Vitamin B 12

Criteria

Inclusion Criteria:

• Patients will be included in the study are aged from18- 60 yrs old undergoing CABG and/or valve surgery on CPB and have 2 or more preoperative risk factors for Vasoplegia,

• Using preoperative beta blocker (BB) or Angiotensin converting enzyme inhibitor (ACEI).

• preoperative EF < 35%

• History of thyroid disease

• Preoperative diuretics

Exclusion Criteria:

• Exclusion criteria are:

1. Emergency surgery

2. Severe renal Insufficiency (preoperative Cr > 1.8 mg / dL)

3. Severe hepatic disease (preoperative diagnosis of liver cirrhosis or recent elevated liver function tests

4. Pregnant or woman of child bearing potential

5. Know hypersensitivity to hydroxycobolamin