Role of Vitamin C in Cardiac Vasoplegia After Cardiopulmonary Bypass

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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04519281
• Other study ID #: N-17-2020
• Status: Recruiting
• Start date: April 16, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• 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
• Vasoplegia

Intervention

Drug:
• IV of vitamin C
administration of high-dose of IV vitamin C perioperatively

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	duration of noradrenaline need	to study the effect of vitamin C administration on the time to weaning from noradrenaline	3 days