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

Postoperative Pulmonary Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03756727
• Other study ID #: XYFY-2018-1101
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 1, 2018
• Est. completion date: July 2019

Study information

• Verified date: November 2018
• Source: Xuzhou Medical University
• Contact: Jin Dong Liu, M.S
• Phone: +86-13951355136
• Email: liujindong1818[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: July 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Pulmonary Complications

Intervention

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

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Epub 2016 Nov 2. Review. — View 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. — View Citation

Mazo V, Sabaté 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of postoperative pulmonary complications	Use 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.	an average of 2 weeks
Secondary	incidence of postoperative pulmonary complications	incidence of postoperative pulmonary complications during hospital stay	an average of 10 days
Secondary	length of ICU stay and length of hospital stay	all patients transfer to ICU after surgery	an average of 10 days
Secondary	extubation and wake time	length of extubation time,length of wake time	an average of 1 day
Secondary	PaO2/FiO2	Oxygenation index (PaO2/FiO2) in millimeter mercury column.	1 day, 3 days,5 days post surgery
Secondary	A-aDO2	alveolar-arterial oxygen tension difference (A-aDO2)	1 day, 3 days,5 days post surgery
Secondary	Plateau pressure	Plateau pressure in centimeter water column	an average of 1 day
Secondary	Peak airway pressure	Peak airway pressure in centimeter water column	an average of 1 day
Secondary	positive end expiratory pressure	positive end expiratory pressure in centimeter water column	an average of 1 day
Secondary	lung compliance	lung compliance in Milliliter/ centimeter water column	an average of 1 day
Secondary	post-hospitalization follow-up	record the incidence of postoperative pulmonary complications after hospital discharged.	once a day till 30 days post-hospitalization