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NCT Number: NCT06723626

Effects of Vitamin C on Shock Duration and 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vit C

Drug

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

Standard Preparation

Drug

Patients in the control group received standard care.

Other names: standard care

Primary outcomes

  1. shock duration

    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.

Secondary outcomes

  1. proportion of perfused vessels (PPV)

    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.

  2. perfused vessel density (PVD)

    Time frame: 24 hours after treatment

    A core parameter in sublingual microcirculation monitoring, used to quantify functional capillary density.

  3. heterogeneity index (HI)

    Time frame: 24 hours after treatment

    A parameter in sublingual microcirculation monitoring used to quantify the spatial heterogeneity of microvascular perfusion.

  4. ICU length of stay

    Time frame: 28 days after treatment

    Time from admission to ICU until discharge from ICU

  5. mechanical ventilation duration

    Time frame: 28 days after treatment

    the time from the start of mechanical ventilation therapy to the complete discontinuation of mechanical ventilation

  6. 28-d Mortality

    Time frame: 28 days after treatment

    patients with sepsis who died after treatment from any cause within 28 days

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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