An interventional study of Vit C and Standard Preparation in Vasoplegia Syndrome, sponsored by Southeast University, China. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Southeast University, China · Not applicable, Interventional, and Treatment
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.
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.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's enrollment of 40 is below the median of 110 across 27 interventional studies indexed under Vasoplegia.
Browse Vasoplegia studies →Southeast University, China is the lead sponsor of 168 studies on the registry; 45 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the intervention group received IV vitamin C (1.5g every 6 hours).
Drug: Vit C
Patients in the control group received nothing.
Drug: Standard Preparation
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.
Also known as: vitamin C, standard care
Patients in the control group received standard care.
Also known as: standard care
shock duration
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: 28 days after treatment
proportion of perfused vessels (PPV)
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
perfused vessel density (PVD)
A core parameter in sublingual microcirculation monitoring, used to quantify functional capillary density.
Time frame: 24 hours after treatment
heterogeneity index (HI)
A parameter in sublingual microcirculation monitoring used to quantify the spatial heterogeneity of microvascular perfusion.
Time frame: 24 hours after treatment
ICU length of stay
Time from admission to ICU until discharge from ICU
Time frame: 28 days after treatment
mechanical ventilation duration
the time from the start of mechanical ventilation therapy to the complete discontinuation of mechanical ventilation
Time frame: 28 days after treatment
28-d Mortality
patients with sepsis who died after treatment from any cause within 28 days
Time frame: 28 days after treatment
Ran from Jul 2024 to primary completion in Aug 2026, 25 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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