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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pulmonary Complications
• Intervention / Treatment: Drug: Ascorbic Acid; Drug: Saline

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ascorbic acid group; the patients received 2g of intravenous Ascorbic acid at the night before surgery, during the surgery and five days after surgery.	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).; Other Names: Vitamin c
Placebo Comparator: Control comparator group; the patients received 10ml saline at the night before surgery, during the surgery and five days after surgery.	Drug: 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).; Other Names: Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuzhou Medical University
• Investigators: Principal Investigator: Jin Dong Liu, M.S, The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): May 30, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: XYFY-2018-1101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Individual Participant Data(IPD) will be available when this trial is finished and the article have been published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No