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

NCT06160219 | Completed Phase 2

• 1 other identifier: FMASU R46/2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasoplegic Syndrome

Outcome Measures

Primary Outcomes (1)

• change in systemic vascular resistance

  Primary 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.

  within 30 and 60 minutes

Study Arms (2)

Group (OH CO)

ACTIVE COMPARATOR

Group (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.

Drug: Hydroxycobalamin

Group (C) control

PLACEBO COMPARATOR

Group (C) control: 30 patients will receive 200ml of NS over 15 min iv.

Drug: Hydroxycobalamin

Interventions

Hydroxycobalamin DRUG

prophylactic use of hydroxycobalamin in vasoplegia in high risk patients undergoing cardiac surgeries

Also known as: Synthetic vitamin B12 ( cyanokit)

Group (C) control; Group (OH CO)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Emergency surgery
• Severe renal Insufficiency (preoperative Cr \> 1.8 mg / dL)
• Severe hepatic disease (preoperative diagnosis of liver cirrhosis or recent elevated liver function tests
• Pregnant or woman of child bearing potential
• Know hypersensitivity to hydroxycobolamin

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Vasoplegia

Interventions

Hydroxocobalamin; Vitamin B 12

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Dina Badre, MD

  Associate Professor of Anesthesia and ICU , Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Model Details: At the end of CPB, the patients will be assigned randomly into 2 groups by using computer generated random numbers sequences and sealed envelopes. Group (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. Group (C) control: 30 patients will receive 200ml of NS over 15 min iv. Primary 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. Secondary outcomes were:

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: August 28, 2019
• Primary Completion: November 20, 2023
• Study Completion: November 27, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: within 6 months for 4 years time
• Access Criteria: all IPD data of protocol, results and discussion.

Locations

EG (1)