Effects of Vitamin C on Shock Duration and Microcirculation in Patients With Vasoplegia Syndrome After Cardiac Surgery

Clinical Study of the Effect of Intravenous Vitamin C on the Prognosis and Sublingual Microcirculation in Patients With Vasoplegia Syndrome After Cardiac Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Vasoplegia Syndrome
• Intervention / Treatment: Drug: Vit C; Drug: Standard Preparation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vitamin C and standard care; Patients in the intervention group received IV vitamin C (1.5g every 6 hours).	Drug: Vit C; 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: standard care; vitamin C
Placebo Comparator: standard care; Patients in the control group received nothing.	Drug: Standard Preparation; Patients in the control group received standard care.; Other Names: standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-d Mortality	patients with sepsis who died after treatment from any cause within 28 days	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.	24 hours after treatment
perfused vessel density (PVD)	A core parameter in sublingual microcirculation monitoring, used to quantify functional capillary density.	24 hours after treatment
heterogeneity index (HI)	A parameter in sublingual microcirculation monitoring used to quantify the spatial heterogeneity of microvascular perfusion.	24 hours after treatment
ICU length of stay	Time from admission to ICU until discharge from ICU	28 days after treatment
mechanical ventilation duration	the time from the start of mechanical ventilation therapy to the complete discontinuation of mechanical ventilation	28 days after treatment

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: Jingyuan Xu, M.D., Zhongda hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): August 31, 2026
• Study Completion (Actual): August 31, 2026

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 13, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: microcirculation; mortality; vasoplegia; vitamin C; vasoplegia syndrome
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vasoplegia; Health Services Administration; Health Care Quality, Access, and Evaluation; Organic Chemicals; Investigative Techniques; Quality of Health Care; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Quality Indicators, Health Care; Weights and Measures; Ascorbic Acid; Standard of Care; Reference Standards
• Other Study ID Numbers: 2023ZDSYLL355-P01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No