Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
NCT Number: NCT06723626
This pilot study intends to observe the effect of intravenous vitamin C on the prognosis and sublingual microcirculation in patients with vasoplegia syndrome after cardiac surgery through a prospective randomized controlled study method.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210009, China
Vasoplegia syndrome is a frequent and severe complication after cardiac surgery (incidence 5-50%), marked by hypotension, normal/high cardiac index, and continuous vasopressor need, leading to prolonged ICU stay, acute kidney injury, and death. Its pathophysiology involves systemic inflammation, excessive nitric oxide, vasopressin depletion, and endothelial dysfunction impairing microcirculation.
Vitamin C, a potent antioxidant, scavenges reactive oxygen species, protects glycocalyx, supports norepinephrine synthesis, and limits iNOS expression, improving microperfusion in experimental models. Plasma vitamin C drops significantly after cardiopulmonary bypass, suggesting increased consumption and potential benefit.
However, clinical evidence is conflicting. Neither trial assessed microcirculatory endpoints, leaving this gap unexplored in randomized studies. Thus, this study aims to evaluate vitamin C's effects on both shock duration and sublingual microcirculation in post-cardiac surgery vasoplegia, addressing the unresolved clinical and mechanistic questions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
included:
Patients in the vitamin C group received standard care (fluid resuscitation, norepinephrine infusion to maintain MAP >65 mmHg, additional vasopressors and hydrocortisone as judged by the attending clinicians) plus intravenous vitamin C (1.5g of vitamin C injection in 100 mL normal saline) over 30 minutes, repeated every 6 hours for a total of 4 doses.
Other names: vitamin C, standard care
Patients in the control group received standard care.
Other names: standard care
Time frame: 28 days after treatment
The primary outcome was shock duration, defined as the time from the start of vasopressor therapy to the complete discontinuation of all vasopressors. Complete discontinuation defined as no vasopressor being administered to maintain a MAP >65 mmHg for a consecutive period of 24 hours.
Time frame: 24 hours after treatment
A core parameter in sublingual microcirculation monitoring, used to quantify the proportion of microvessels that are actually perfused with red blood cells.
Time frame: 24 hours after treatment
A core parameter in sublingual microcirculation monitoring, used to quantify functional capillary density.
Time frame: 24 hours after treatment
A parameter in sublingual microcirculation monitoring used to quantify the spatial heterogeneity of microvascular perfusion.
Time frame: 28 days after treatment
Time from admission to ICU until discharge from ICU
Time frame: 28 days after treatment
the time from the start of mechanical ventilation therapy to the complete discontinuation of mechanical ventilation
Time frame: 28 days after treatment
patients with sepsis who died after treatment from any cause within 28 days
Southeast University, China
Other
Clinical Study of the Effect of Intravenous Vitamin C on the Prognosis and Sublingual Microcirculation in Patients With Vasoplegia Syndrome After Cardiac Surgery.
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