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

FMASU R46/2019

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.

2019-08-28

2023-11-20

2023-11-27

Completed

Early phase I

60

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'At the end of CPB, the patients will be assigned randomly into 2 groups by using computer generated random numbers sequences and sealed envelopes.\n\nGroup (OH CO): 30 patients will receive hydroxycobolamin (Cyanokit) 5 gm intravenously(iv) through the central venous catheter as bolus over 15 min reconstituted in 200 ml of NS.\n\nGroup (C) control: 30 patients will receive 200ml of NS over 15 min iv.\n\nPrimary outcome will be change in MAP between baseline and all time points (30 \\& 60 min after CPB initiation) and (30 \\& 60 min after CPB separation) between the two groups and within the same group.\n\nSecondary outcomes were:', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2024-05-09