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

NCT03756727 | Unknown Early Phase 1 DMC

• 1 other identifier: XYFY-2018-1101
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• incidence of postoperative pulmonary complications

  an average of 10 days

• length of ICU stay and length of hospital stay

  an average of 10 days

• extubation and wake time

  an average of 1 day

• PaO2/FiO2

  1 day, 3 days,5 days post surgery

• A-aDO2

  1 day, 3 days,5 days post surgery

Study Arms (2)

Ascorbic acid group

EXPERIMENTAL

the patients received 2g of intravenous Ascorbic acid at the night before surgery, during the surgery and five days after surgery.

Drug: Ascorbic Acid

Control comparator group

PLACEBO COMPARATOR

the patients received 10ml saline at the night before surgery, during the surgery and five days after surgery.

Drug: Saline

Interventions

Ascorbic Acid DRUG

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).

Also known as: Vitamin c

Ascorbic acid group

Saline DRUG

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

Also known as: Saline Solution

Control comparator group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-60 years old
• Selective cardiac surgery under cardiopulmonary bypass

You may not qualify if:

• Emergency surgery
• Previous cardiac surgery
• Severe lung disease
• BMI\<18 or \>30
• Mean pulmonary arterial pressure \>40 mmHg
• were allergic to ascorbic acid

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Related Publications (3)

• 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.

  PMID: 24901240 BACKGROUND

• 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.

  PMID: 27806938 BACKGROUND

• 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.

  PMID: 28322416 BACKGROUND

MeSH Terms

Interventions

Ascorbic Acid; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jin Dong Liu, M.S

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Dong Liu, M.S

CONTACT

+86-13951355136; liujindong1818@163.com

Dongyue Wang

CONTACT

+86-15996931208; 763996674@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 28, 2018
• Study Start: December 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: July 1, 2019
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

CN (1)