Status:
COMPLETED
Prophylactic Use of Hydroxycobolamin in Vasoplegic Syndrome in Adult Patients Undergoing Cardiopulmonary Bypass
Lead Sponsor:
Ain Shams University
Conditions:
Vasoplegic Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
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...
Detailed Description
Patients and methods This randomized placebo-controlled single -center study will be conducted in Ain Shams University Hospital from May 2019 till October 2022. Patients undergoing Cardiopulmonary by...
Eligibility Criteria
Inclusion
- 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
- Exclusion criteria are:
- 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
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06160219
Start Date
August 28 2019
End Date
November 27 2023
Last Update
June 12 2024
Active Locations (1)
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1
AinShams university hospitals
Cairo, Egypt