Clinical Study of the Effect of Intravenous Vitamin C on the Prognosis and Sublingual Microcirculation in Patients With Vasoplegia Syndrome After Cardiac Surgery.
| Registry | NCT06723626 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | Southeast University, China (Other) |
| Conditions | Vasoplegia Syndrome |
| Interventions | Vit C, Standard Preparation (Drug) |
| Dates | start 2024-07-01, primary completion 2026-08-31, completion 2026-08-31, first posted 2024-12-09, last updated 2026-09-16 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Vasoplegia Syndrome All trials of Vit C All trials of Standard Preparation
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| vitamin C and standard care | Experimental | Drug: Vit C | Patients in the intervention group received IV vitamin C (1.5g every 6 hours). |
| standard care | Placebo comparator | Drug: Standard Preparation | Patients in the control group received nothing. |
Sex: All, ages: 18 Years to 85 Years
Inclusion Criteria: * Age 18-85 years; * Patients who develop vasoplegia syndrome within 6 hours after being admitted to the ICU following cardiac surgery * Signing informed consent. Exclusion criteria included: * Emergency surgery; * Sepsis shock, postoperative cardiogenic shock or hemorrhagic shock; * Pregnancy or lactation; * Allergy to vitamin C; * Inability to obtain clear sublingual microcirculatory images due to any cause; * Judgment by the attending physician that the patient was unsuitable for enrollment.
| Facility | City | Country | Status |
|---|---|---|---|
| Zhongda Hospital Southeast University | Nanjing, Jiangsu | China |