Clinical trial NCT03756727: Effect of Ascorbic Acid on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery
Official title: Effect of Perioperative Application of Ascorbic Acid on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Postoperative Pulmonary Complications
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 .

Eligibility criteria: 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

Primary outcomes:
measure: severity of postoperative pulmonary complications
timeFrame: an average of 2 weeks
Secondary outcomes:
measure: incidence of postoperative pulmonary complications
timeFrame: an average of 10 days
measure: length of ICU stay and length of hospital stay
timeFrame: an average of 10 days
measure: extubation and wake time
timeFrame: an average of 1 day
measure: PaO2/FiO2
timeFrame: 1 day, 3 days,5 days post surgery
measure: A-aDO2
timeFrame: 1 day, 3 days,5 days post surgery
measure: Plateau pressure
timeFrame: an average of 1 day
measure: Peak airway pressure
timeFrame: an average of 1 day
measure: positive end expiratory pressure
timeFrame: an average of 1 day
measure: lung compliance
timeFrame: an average of 1 day
measure: post-hospitalization follow-up
timeFrame: once a day till 30 days post-hospitalization
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Jin Dong Liu, M.S
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.
citation: Baker WL, Coleman CI. Meta-analysis of ascorbic acid for prevention of postoperative atrial fibrillation after cardiac surgery. Am J Health Syst Pharm. 2016 Dec 15;73(24):2056-2066. doi: 10.2146/ajhp160066. Epub 2016 Nov 2.
citation: Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297.