Vasoplegia SyndromeNCT06723626
Effects of Vitamin C on Shock Duration and Microcirculation in Patients With Vasoplegia Syndrome After Cardiac Surgery
A study testing Vit C and Standard Preparation in people with Vasoplegia Syndrome, run by Southeast University, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vasoplegia Syndrome
- What is being tested?
- Vit C and Standard Preparation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years;
- Patients who develop vasoplegia syndrome within 6 hours after being admitted to the ICU following cardiac surgery
- Signing informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vasoplegia Syndrome
- Being tested
- Vit C, Standard Preparation
- Keywords
- vitamin C, mortality, microcirculation, vasoplegia syndrome, vasoplegia
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit CDrug
Also called vitamin C, standard care
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.
Standard PreparationDrug
Also called standard care
Patients in the control group received standard care.
| Study group | Role | What they receive |
|---|---|---|
| vitamin C and standard care | Experimental | Patients in the intervention group received IV vitamin C (1.5g every 6 hours). Receives: Drug: Vit C |
| standard care | Placebo comparator | Patients in the control group received nothing. Receives: Drug: Standard Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after treatment
Secondary outcomes (6)
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.
Measured: 24 hours after treatment
perfused vessel density (PVD)
A core parameter in sublingual microcirculation monitoring, used to quantify functional capillary density.
Measured: 24 hours after treatment
heterogeneity index (HI)
A parameter in sublingual microcirculation monitoring used to quantify the spatial heterogeneity of microvascular perfusion.
Measured: 24 hours after treatment
ICU length of stay
Time from admission to ICU until discharge from ICU
Measured: 28 days after treatment
mechanical ventilation duration
the time from the start of mechanical ventilation therapy to the complete discontinuation of mechanical ventilation
Measured: 28 days after treatment
28-d Mortality
patients with sepsis who died after treatment from any cause within 28 days
Measured: 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jul 2024
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasoplegia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Jingyuan Xu, M.D., Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723626
- Sponsor's protocol ID
- 2023ZDSYLL355-P01
- Status last verified
- Sep 2026
- First submitted
- 21 May 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Effect of Intravenous Vitamin C on the Prognosis and Sublingual Microcirculation in Patients With Vasoplegia Syndrome After Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT06723626
- Acronym / sponsor ID
- 2023ZDSYLL355-P01
- Conditions
- Vasoplegia Syndrome
- Keywords
- vitamin C, mortality, microcirculation, vasoplegia syndrome, vasoplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin C and standard care | Experimental | Drug: Vit CPatients in the intervention group received IV vitamin C (1.5g every 6 hours). |
| standard care | Placebo comparator | Drug: Standard PreparationPatients in the control group received nothing. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-85 years;
- Patients who develop vasoplegia syndrome within 6 hours after being admitted to the ICU following cardiac surgery
- Signing informed consent.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vit CAlso: vitamin C, standard carePatients 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. | Drug | vitamin C and standard care |
| Standard PreparationAlso: standard carePatients in the control group received standard care. | Drug | standard care |
Primary outcome
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.
6 secondary outcomes
proportion of perfused vessels (PPV)
Time frame: 24 hours after treatment
perfused vessel density (PVD)
Time frame: 24 hours after treatment
heterogeneity index (HI)
Time frame: 24 hours after treatment
ICU length of stay
Time frame: 28 days after treatment
mechanical ventilation duration
Time frame: 28 days after treatment
28-d Mortality
Time frame: 28 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyuan Xu, M.D. principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vit C and Standard Preparation in people with Vasoplegia Syndrome, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shock duration (time frame: 28 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.