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Effect of Ascorbic Acid on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery

Effect of Perioperative Application of Ascorbic Acid on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03756727
Enrollment
110
Registered
2018-11-28
Start date
2018-12-01
Completion date
2019-07-31
Last updated
2018-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pulmonary Complications

Brief summary

Postoperative pulmonary complications(PPCs) including, but not limited to ,hypoxemia, pneumonia, ventilator-induced lung injury, and acute respiratory distress syndrome (ARDS),atelectasis,pleural effusion .PPCs may result in increased resources utilization, delayed mobilization, prolonged need of supplemental oxygen or mechanical ventilation,and a longer hospital stay.postoperative pulmonary complications are common after cardiac surgery, often increasing postoperative morbidity and mortality.The extracorporeal circulation,increased oxygen concentration inhaled and the development of massive atelectasis after open-chest surgery commonly activate lung inflammation, amplifying the harm Injury of pulmonary .Currently, plenty of interventions have been studied to prevent PPCs after surgery. Most of the recent research has focused on physical therapy such as lung-protective modes during intraoperative mechanical ventilation, Alveolar Recruitment, and respiratory muscle training.These therapies have a certain effect, but still not satisfactory.Ascorbic acid is an important cofactor in multiple enzymatic reactions where its main function is as a reducing agent.Studies have shown that ascorbic acid can reduce both ischemia-reperfusion injury and oxidative stress. Unfortunately, no studies examined whether Ascorbic acid can reduce PPCs.

Detailed description

The possible mechanisms of ascorbic acid to alleviate ischemia-reperfusion injury are as follows: 1 Ascorbic acid as a first-line antioxidant in plasma can reduce stress by eliminating excess Reactive oxygen species and reduce damage. 2 provides rapid electron transfer to react with superoxide and hydroxyl group to scavenge reactive oxygen released into the circulation. 3 Ascorbic acid can reduce lipid peroxidation and reduce lung injury caused by ischemia-reperfusion by scavenging oxygen free radicals. 4 Vitamin C can promote the production of cytokines by immune cells to reduce local inflammatory reactions and improve tissue microcirculation.The study aims to explore whether daily used Ascorbic acid in the perioperative period has a preventive effect on PPCs in patients undergoing cardiac surgery, and through short-term and long-term follow-up, to investigate the effect on post-hospitalization Prognosis .

Interventions

DRUGAscorbic Acid

Patients in Ascorbic acid group received 2g of intravenous Ascorbic acid at the night before surgery, during the surgery and five days after surgery (once a day).

DRUGSaline

Patients in Control Comparator group received saline 10ml at the night before surgery, during the surgery and five days after surgery (once a day).

Sponsors

Xuzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 18-60 years old 2. Selective cardiac surgery under cardiopulmonary bypass

Exclusion criteria

1. Emergency surgery 2. Previous cardiac surgery 3. Severe lung disease 4. BMI\<18 or \>30 5. Mean pulmonary arterial pressure \>40 mmHg 6. were allergic to ascorbic acid

Design outcomes

Primary

MeasureTime frameDescription
severity of postoperative pulmonary complicationsan average of 2 weeksUse the postoperative pulmonary complications score to record the severity. scored ranging from 0 to 5.Scored the severity once a day, record the highest score.

Secondary

MeasureTime frameDescription
length of ICU stay and length of hospital stayan average of 10 daysall patients transfer to ICU after surgery
extubation and wake timean average of 1 daylength of extubation time,length of wake time
PaO2/FiO21 day, 3 days,5 days post surgeryOxygenation index (PaO2/FiO2) in millimeter mercury column.
A-aDO21 day, 3 days,5 days post surgeryalveolar-arterial oxygen tension difference (A-aDO2)
incidence of postoperative pulmonary complicationsan average of 10 daysincidence of postoperative pulmonary complications during hospital stay
Peak airway pressurean average of 1 dayPeak airway pressure in centimeter water column
positive end expiratory pressurean average of 1 daypositive end expiratory pressure in centimeter water column
lung compliancean average of 1 daylung compliance in Milliliter/ centimeter water column
post-hospitalization follow-uponce a day till 30 days post-hospitalizationrecord the incidence of postoperative pulmonary complications after hospital discharged.
Plateau pressurean average of 1 dayPlateau pressure in centimeter water column

Countries

China

Contacts

Primary ContactJin Dong Liu, M.S
liujindong1818@163.com+86-13951355136
Backup ContactDongyue Wang
763996674@qq.com+86-15996931208

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026