None listed
Conditions
Brief 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.
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 ICU, whichever occurs first) with clinical monitoring and evaluation of the patient's blood pressure prior to study drug administration
Sponsors
Austin Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
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
Outcome results
None listed