Role of Vitamin C in Cardiac Vasoplegia After Cardiopulmonary Bypass

Role of Preoperative IV Administration of Vitamin C in Patients at Risk for Cardiac Vasoplegia After Cardiopulmonary Bypass

This is a parallel group double-blind, randomized-controlled trial with 1:1 randomization ratio which will be conducted over a period of 6 months to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB. Two groups will be included; Group (A) patients undergoing open heart surgeries who will receive IV ascorbic acid (treatment group) and Group (B) patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (control group). Each patient will be subjected to assessments of the doses of noradrenaline given from the end of surgery until weaning as well as hemodynamics in the first 2 hours and then at intervals of 6 hours up to 3 days following surgery.

Study Overview

• Status: Unknown
• Conditions: to Study the Effect of Vitamin C Administration on the Amount and the Time of Weaning of Noradrenaline Given Post-operatively to Patients After CPB
• Intervention / Treatment: Drug: IV of vitamin C

Detailed Description

Background and Rationale:

Cardiac vasoplegia is a known phenomenon after cardiopulmonary bypass (CPB) occurring in up to 44% of patients. Severe forms of such condition refractory to vasopressors are associated with poor outcomes. New agents e.g. ascorbic acid that can alter the systemic vascular resistance in cardiac vasoplegia have been suggested as an attempt to avoid or at least reduce the use of IV vasopressors and their induced systemic hypo-perfusion.

Objectives :

• Primary objective: to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB
• Secondary objectives: to study the effect of vitamin C administration on the time to weaning from noradrenaline

Study population & Sample size :

Patients undergoing cardiac surgeries with CPB having risk factors for cardiac vasoplegia like diabetes mellitus and chronic renal failure.

50 patients will be needed in each group (treatment and control)

Study Design :

A parallel group double-blind, randomized-controlled trial, with 1:1 randomization ratio 2 groups will be included;

-Group (A) patients undergoing open heart surgeries who will receive IV ascorbic acid. -Group (B) patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (Control Group).

Methods :

Each patient will be subjected to the following assessments:

-Pre-operative patient characteristics: demographic data, co-morbidities, pre-operative echo findings,… -Intra-operative details: procedures, time parameters,… the doses of noradrenaline given from the end of surgery until weaning or death and hemodynamics in the first 2 hours and then at intervals of 6 hours up to 3 days following surgery. -Postoperative data: echo parameters, patient outcome, time of discharge,…

Outcome parameter (s):

-Primary outcome: the area under the dose-time curve of noradrenaline -Secondary outcome measures: the duration of vasopressor (noradrenaline) infusion till weaning up to 3 days following surgery.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11956
    • Recruiting
    • Cairo University
    • Contact: Noha Asem, MD; Phone Number: 00201003657120; Email: kasralainirec@gmail.com
    • Sub-Investigator: Soha Elmorsy, MD
    • Sub-Investigator: Wael Siory, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A parallel group double-blind, randomized-controlled trial, with 1:1 randomization ratio 2 groups will be included;

• Group (A) consists of 50 patients undergoing open heart surgeries who will receive IV ascorbic acid.
• Group (B) consists of 50 patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (Control Group).

Description

Inclusion Criteria:

• Patients undergoing cardiac surgeries with CPB having risk factors for cardiac vasoplegia like diabetes mellitus and chronic renal failure.

Exclusion Criteria:

• Patients who undergo surgeries without cardiopulmonary bypass (off-pump)
• Patients undergoing surgeries for congenital cardiac disease
• Patients performing heart transplantation and combined cardiac surgeries
• Patients with low pre-operative left ventricular ejection fraction (LVEF)
• Patients refusing to participate
• Patients who receive vasopressors other than noradrenaline

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group (A); consists of 50 patients undergoing open heart surgeries who will receive IV ascorbic acid	Drug: IV of vitamin C; administration of high-dose of IV vitamin C perioperatively
Group (B); consists of 50 patients undergoing open heart surgeries who will not receive ascorbic acid or will receive a placebo (Control Group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of noradrenaline need	to study the effect of vitamin C administration on the amount of noradrenaline given post-operatively to patients after CPB	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of noradrenaline need	to study the effect of vitamin C administration on the time to weaning from noradrenaline	3 days

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Fischer GW, Levin MA. Vasoplegia during cardiac surgery: current concepts and management. Semin Thorac Cardiovasc Surg. 2010 Summer;22(2):140-4. doi: 10.1053/j.semtcvs.2010.09.007.
• Omar S, Zedan A, Nugent K. Cardiac vasoplegia syndrome: pathophysiology, risk factors and treatment. Am J Med Sci. 2015 Jan;349(1):80-8. doi: 10.1097/MAJ.0000000000000341.
• Wieruszewski PM, Nei SD, Maltais S, Schaff HV, Wittwer ED. Vitamin C for Vasoplegia After Cardiopulmonary Bypass: A Case Series. A A Pract. 2018 Aug 15;11(4):96-99. doi: 10.1213/XAA.0000000000000752.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Anticipated): October 15, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Vasoplegia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: N-17-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Clinical outcomes are to be shared