Postoperative Pulmonary ComplicationsEarly Phase 1NCT03756727
Effect of Ascorbic Acid on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery
A Early Phase 1 study testing Ascorbic Acid and Saline in people with Postoperative Pulmonary Complications, run by Xuzhou Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pulmonary Complications
- What is being tested?
- Ascorbic Acid and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to Jul 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-60 years old
- Selective cardiac surgery under cardiopulmonary bypass
Who cannot join
- Emergency surgery
- Previous cardiac surgery
- Severe lung disease
- BMI<18 or >30
- Mean pulmonary arterial pressure >40 mmHg
- were allergic to ascorbic acid
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
About this study
Official title: 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.
Read the 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 .
- Conditions
- Postoperative Pulmonary Complications
- Being tested
- Ascorbic Acid, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Vitamin c
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).
SalineDrug
Also called Saline Solution
Patients in Control Comparator group received saline 10ml at the night before surgery, during the surgery and five days after surgery (once a day).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: an average of 2 weeks
Secondary outcomes (10)
incidence of postoperative pulmonary complications
incidence of postoperative pulmonary complications during hospital stay
Measured: an average of 10 days
length of ICU stay and length of hospital stay
all patients transfer to ICU after surgery
Measured: an average of 10 days
extubation and wake time
length of extubation time,length of wake time
Measured: an average of 1 day
PaO2/FiO2
Oxygenation index (PaO2/FiO2) in millimeter mercury column.
Measured: 1 day, 3 days,5 days post surgery
A-aDO2
alveolar-arterial oxygen tension difference (A-aDO2)
Measured: 1 day, 3 days,5 days post surgery
Plateau pressure
Plateau pressure in centimeter water column
Measured: an average of 1 day
Peak airway pressure
Peak airway pressure in centimeter water column
Measured: an average of 1 day
positive end expiratory pressure
positive end expiratory pressure in centimeter water column
Measured: an average of 1 day
lung compliance
lung compliance in Milliliter/ centimeter water column
Measured: an average of 1 day
post-hospitalization follow-up
record the incidence of postoperative pulmonary complications after hospital discharged.
Measured: once a day till 30 days post-hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Dong Liu, Xuzhou Medical University
- Investigators
- Jin Dong Liu, M.S, Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756727
- Sponsor's protocol ID
- XYFY-2018-1101
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data(IPD) will be available when this trial is finished and the article have been published
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.
PubMed 24901240Baker 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.
PubMed 27806938Costa 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.
PubMed 28322416
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Application of Ascorbic Acid on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03756727
- Acronym / sponsor ID
- XYFY-2018-1101
- Conditions
- Postoperative Pulmonary Complications
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascorbic acid group | Experimental | Drug: Ascorbic Acidthe patients received 2g of intravenous Ascorbic acid at the night before surgery, during the surgery and five days after surgery. |
| Control comparator group | Placebo comparator | Drug: Salinethe patients received 10ml saline at the night before surgery, during the surgery and five days after surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18-60 years old
- Selective cardiac surgery under cardiopulmonary bypass
Key exclusion criteria (6 listed)
- Emergency surgery
- Previous cardiac surgery
- Severe lung disease
- BMI<18 or >30
- Mean pulmonary arterial pressure >40 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic AcidAlso: Vitamin cPatients 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). | Drug | Ascorbic acid group |
| SalineAlso: Saline SolutionPatients in Control Comparator group received saline 10ml at the night before surgery, during the surgery and five days after surgery (once a day). | Drug | Control comparator group |
Primary outcome
severity of postoperative pulmonary complications
Time frame: an average of 2 weeks
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.
10 secondary outcomes
incidence of postoperative pulmonary complications
Time frame: an average of 10 days
length of ICU stay and length of hospital stay
Time frame: an average of 10 days
extubation and wake time
Time frame: an average of 1 day
PaO2/FiO2
Time frame: 1 day, 3 days,5 days post surgery
A-aDO2
Time frame: 1 day, 3 days,5 days post surgery
Plateau pressure
Time frame: an average of 1 day
Peak airway pressure
Time frame: an average of 1 day
positive end expiratory pressure
Time frame: an average of 1 day
lung compliance
Time frame: an average of 1 day
post-hospitalization follow-up
Time frame: once a day till 30 days post-hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Background: PubMed 24901240Mazo 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.
- Background: PubMed 27806938Baker 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.
- Background: PubMed 28322416Costa 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.
- Individual participant dataSharing planned: Undecided. Individual Participant Data(IPD) will be available when this trial is finished and the article have been published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Dong Liu, M.S principal investigator
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ascorbic Acid and Saline in people with Postoperative Pulmonary Complications, run by Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Dong Liu, M.S (+86-13951355136, liujindong1818@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of postoperative pulmonary complications (time frame: an average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03756727, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.