CompletedPhase 2ACTRN12617000793314

The Vitamin C after Cardiac Surgery Study

A Pilot, Randomised, Double-Blind Study of Vitamin C in the treatment of Vasoplegic Shock after Cardiac Surgery

Sponsor

Austin Hospital

Enrollment

50 participants

Start Date

Nov 9, 2017

Study Type

Interventional

Conditions

Low blood pressure Vasoplegia

Summary

Patients after cardiac surgery often develop a low blood pressure because of the inflammation associated with surgery and bypass. This low blood pressure is mostly due to the small blood vessels losing their normal tightness. This condition is called “vasoplegia”. When vasoplegia occurs after cardiac surgery, it can lower the blood pressure to dangerous levels, which can lead to organ malfunction and may even be life-threatening. In order to maintain safety under such a situation, intensive care doctors administer drugs that tighten blood vessels. These drugs are called vasopressors. Such vasopressors can restore safe levels of blood pressure. However, they have significant side effects. Thus, it would be desirable to restore a safe blood pressure without the use of such vasopressor drugs. Over the last few years, evidence has emerged that high dose vitamin C injected into the blood stream can restore the normal tightness of blood vessels and is free of side effects. This makes treatment with vitamin C potentially desirable in cardiac surgery patients with vasoplegia. However, no studies have assessed whether vitamin C at high dose is effective in this setting. Thus, we propose to conduct a pilot study to test whether vitamin C at high dose can improve blood pressure and decrease the need for vasopressor drugs in patients with vasoplegia after cardiac surgery.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

Patients aged greater than or equal to 18 years
Admitted to the ICU for less than 6 hours following cardiac surgery
Vasoplegic syndrome in the postoperative period defined as:
a) need for continuous vasopressor infusion to maintain a mean arterial pressure greater than 65 mmHg AND
b) cardiac index equal to or greater than 2.2 L/min/m2 OR central venous O2 saturation less than 60%

Exclusion Criteria9

Pregnancy
Use of vasopressors or inotropes in the preoperative period
Off-pump cardiac surgery
Chronic use of corticosteroid therapy
History of oxalate nephrolithiasis
Haemochromatosis
Glucose 6 phosphate dehydrogenase deficiency
Treating physician believes there is a cause for shock other than vasoplegic syndrome (eg: bleeding, fluid requirement, pneumothorax, pacemaker issues, or heart failure)
Treating clinician believes the study is not in the patient’s best interests

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Interventions

Intravenous Vitamin C 1500 mg administered 6-hourly given every six hours until no vasopressor is required for a period of 24 hours or a maximum of 96 hours (4 days) or the patient is discharged from

Intravenous Vitamin C 1500 mg administered 6-hourly given every six hours until no vasopressor is required for a period of 24 hours or a maximum of 96 hours (4 days) or the patient is discharged from ICU, whichever occurs first) with clinical monitoring and evaluation of the patient's blood pressure prior to study drug administration