Ascorbic AcidPhase 2NCT06421688
Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery
A Phase 2 study testing Ascorbic acid and Saline in people with Ascorbic Acid and Neurosurgical Procedures, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate the effect of perioperative administration of vitamin C on postoperative pulmonary complications, with the aim of providing a safe and effective medication regimen for the prevention and treatment of postoperative pulmonary complications in patients undergoing surgery… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ascorbic Acid, Neurosurgical Procedures, Humans
- 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
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to Jun 2025
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who need craniotomy treatment due to intracranial tumors;
- age 18-75 years old;
- American Society of Anesthesiologists classification: 1~3;
- Patients and their families agree to participate in the study and sign the informed consent form.
Who cannot join
- Patients with severe pulmonary infection or respiratory failure prior to surgery;
- Patients with previous history of neurological or psychiatric diseases;
- Patients with cardiac, hepatic and renal insufficiency;
- patients who are receiving parenteral nutrition;
- pregnant patients;
- Patients ruled out by medication instructions;
Show all 9Show fewer
- Patients who require emergency surgery;
- patients with combination of other malignant tumors;
- patients who have participated in other clinical studies of drugs within 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
Dong Wang, Doctor of Medicine(M.D.), +86-18353173516, ngbaise@163.com
About this study
Official title: Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial: a Randomized, Double-blind, Placebo-controlled Study
The goal of this clinical trial is to investigate the effect of perioperative administration of vitamin C on postoperative pulmonary complications, with the aim of providing a safe and effective medication regimen for the prevention and treatment of postoperative pulmonary complications in patients undergoing surgery for craniocerebral tumors. The main questions it aims to answer are:
- To determine whether vitamin C can reduce pulmonary complications after surgery for intracranial tumors.
- Does intraoperative vitamin C improve the prognosis of surgical patients
Read more
Researchers will compare vitamin C to a placebo (saline) to see if vitamin C is effective for postoperative lung complications in patients undergoing surgery for cranial tumors.
- Participants will be intravenously pumped with vitamin C for two hours after induction of anesthesia.
- Participants will have intraoperative plasma sampling and recording of ventilator parameters, monitor parameters and perioperative data.
- Participants will be followed up until discharge from the hospital to record symptoms and adverse events, and will be called at six months to check on their prognosis.
Read the detailed description
Neurosurgery has a high incidence of postoperative pulmonary complications, increasing patient costs and affecting patient prognosis. Neurosurgery often requires hyperventilation to reduce intracranial pressure, so methods to reduce postoperative pulmonary complications such as small tidal volumes cannot be used routinely, and larger tidal volumes often result in injury to pulmonary endothelial cells, which leads to increased permeability of the pulmonary microvasculature, resulting in mechanically ventilated lung injury. Of course surgical injuries and mechanical ventilation can also cause oxidative stress injury to the lungs. Vitamin C is a common antioxidant drug and cofactor in the synthesis of many substances in the body, and many studies have shown that vitamin C prevents the increase in endothelial barrier permeability due to many causes. During the COVID-19 epidemic, vitamin C is seen as an important adjunct in preventing and ameliorating symptoms of COVID-19 patients. not only that, but vitamin C also assisted in postoperative analgesia and promote incision healing, so investigators would like to observe that by giving vitamin C during the surgery is able to prevent the occurrence of postoperative pulmonary complications or improve the prognosis of participants.
- Conditions
- Ascorbic Acid, Neurosurgical Procedures, Humans, Ventilator-Induced Lung Injury, Postoperative Complications
- Being tested
- Ascorbic acid, Saline
- Medical subject headings
- Ventilator-Induced Lung Injury, Postoperative Complications
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
After participants underwent induction of anesthesia, Ascorbic acid (Vitamin C Injection) was administered at a dosage of 50 mg/kg, diluted to 50 ml using saline, with a total amount not exceeding 4 g; pumping was performed using a micro pump at a rate of 25 ml/h.
SalineDrug
Also called saline (medicine)
After participants underwent induction of anesthesia, 50 ml of saline was used and pumped using a micro pump at a rate of 25 ml/h.
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic acid group | Experimental | Patients received 50 mg/kg of Ascorbic acid after induction of anesthesia Receives: Drug: Ascorbic acid |
| Control comparator group | Placebo comparator | Patients receive 50ml saline after induction of anesthesia Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative pulmonary complications
This will be assessed using the Postoperative Pulmonary Complications Score, which ranges from 0 to 5, with a score of ≥3 being considered positive for postoperative pulmonary complications. It was assessed every day before discharge and the highest score that occurred was recorded.
Measured: About 10 days
Secondary outcomes (12)
Neuron-specific enolase levels
Plasma levels of neuron-specific enolase, unit is ng/ml
Measured: Post operative day 1
Length of hospitalization
Length of time between participant's completion of surgery and discharge
Measured: About 10 days
Oxygenation index
PaO2/FiO2, in millimeters of mercury
Measured: One hour postoperative
Pain scores
Patient's postoperative pain level; Using a "Pain Visual Analogue Scale", a 10-centimeter-long ruler was used, with 0 indicating no pain and 10 representing the most intense pain that was intolerable. During the test, the participant points to the scale that best represents the level of pain, and the researcher assigns the participant a score based on the location of the point.
Measured: 1 day, 3 days, 7 days postoperative
pulmonary compliance
lung compliance in Milliliter/ centimeter water column
Measured: Last hour of surgery.
Interleukin-6
The level of Interleukin-6 in the blood, in nanograms per liter
Measured: 1 day, 3 days, 7 days postoperative
superoxide dismutase (SOD)
Blood levels of superoxide dismutase, in units per milliliter
Measured: 1 day, 3 days, 7 days postoperative
body temperature
Postoperative body temperature in degrees Celsius
Measured: 1 day, 3 days, 7 days postoperative
blood pressure
Systolic and diastolic blood pressure，In millimeters of mercury
Measured: About 10 days
Brain-specific cardiolipin
Plasma levels of brain-specific cardiolipin
Measured: About 3 days
neutrophil
Levels of neutrophils in the blood, measured in units per liter.
Measured: About 10 days
C-reactive protein
Level of C-reactive protein in the blood in milligrams per liter
Measured: 1 day, 3 days, 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ascorbic AcidStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Wang, Qianfoshan Hospital
- Investigators
- Dong Wang, M.D, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421688
- Sponsor's protocol ID
- YXLL-KY-2024(039)
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- 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
Sogame LC, Vidotto MC, Jardim JR, Faresin SM. Incidence and risk factors for postoperative pulmonary complications in elective intracranial surgery. J Neurosurg. 2008 Aug;109(2):222-7. doi: 10.3171/JNS/2008/109/8/0222.
PubMed 18671633May JM, Harrison FE. Role of vitamin C in the function of the vascular endothelium. Antioxid Redox Signal. 2013 Dec 10;19(17):2068-83. doi: 10.1089/ars.2013.5205. Epub 2013 May 29.
PubMed 23581713Holford P, Carr AC, Jovic TH, Ali SR, Whitaker IS, Marik PE, Smith AD. Vitamin C-An Adjunctive Therapy for Respiratory Infection, Sepsis and COVID-19. Nutrients. 2020 Dec 7;12(12):3760. doi: 10.3390/nu12123760.
PubMed 33297491Wang D, Wang M, Zhang H, Zhu H, Zhang N, Liu J. Effect of Intravenous Injection of Vitamin C on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery: A Double-Blind, Randomized Trial. Drug Des Devel Ther. 2020 Aug 11;14:3263-3270. doi: 10.2147/DDDT.S254150. eCollection 2020.
PubMed 32848365Costa 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06421688
- Acronym / sponsor ID
- YXLL-KY-2024(039)
- Conditions
- Ascorbic Acid, Neurosurgical Procedures, Humans, Ventilator-Induced Lung Injury, Postoperative Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 May 2024 (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.
The goal of this clinical trial is to investigate the effect of perioperative administration of vitamin C on postoperative pulmonary complications, with the aim of providing a safe and effective medication regimen for the prevention and treatment of postoperative pulmonary complications in patients undergoing surgery for craniocerebral tumors. The main questions it aims to answer are:
- To determine whether vitamin C can reduce pulmonary complications after surgery for intracranial tumors.
- Does intraoperative vitamin C improve the prognosis of surgical patients
Researchers will compare vitamin C to a placebo (saline) to see if vitamin C is effective for postoperative lung complications in patients undergoing surgery for cranial tumors.
- Participants will be intravenously pumped with vitamin C for two hours after induction of anesthesia.
- Participants will have intraoperative plasma sampling and recording of ventilator parameters, monitor parameters and perioperative data.
- Participants will be followed up until discharge from the hospital to record symptoms and adverse events, and will be called at six months to check on their prognosis.
Detailed description
Neurosurgery has a high incidence of postoperative pulmonary complications, increasing patient costs and affecting patient prognosis. Neurosurgery often requires hyperventilation to reduce intracranial pressure, so methods to reduce postoperative pulmonary complications such as small tidal volumes cannot be used routinely, and larger tidal volumes often result in injury to pulmonary endothelial cells, which leads to increased permeability of the pulmonary microvasculature, resulting in mechanically ventilated lung injury. Of course surgical injuries and mechanical ventilation can also cause oxidative stress injury to the lungs. Vitamin C is a common antioxidant drug and cofactor in the synthesis of many substances in the body, and many studies have shown that vitamin C prevents the increase in endothelial barrier permeability due to many causes. During the COVID-19 epidemic, vitamin C is seen as an important adjunct in preventing and ameliorating symptoms of COVID-19 patients. not only that, but vitamin C also assisted in postoperative analgesia and promote incision healing, so investigators would like to observe that by giving vitamin C during the surgery is able to prevent the occurrence of postoperative pulmonary complications or improve the prognosis of participants.
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 acidPatients received 50 mg/kg of Ascorbic acid after induction of anesthesia |
| Control comparator group | Placebo comparator | Drug: SalinePatients receive 50ml saline after induction of anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who need craniotomy treatment due to intracranial tumors;
- age 18-75 years old;
- American Society of Anesthesiologists classification: 1~3;
- Patients and their families agree to participate in the study and sign the informed consent form.
Key exclusion criteria (9 listed)
- Patients with severe pulmonary infection or respiratory failure prior to surgery;
- Patients with previous history of neurological or psychiatric diseases;
- Patients with cardiac, hepatic and renal insufficiency;
- patients who are receiving parenteral nutrition;
- pregnant patients;
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 CAfter participants underwent induction of anesthesia, Ascorbic acid (Vitamin C Injection) was administered at a dosage of 50 mg/kg, diluted to 50 ml using saline, with a total amount not exceeding 4 g; pumping was performed using a micro pump at a rate of 25 ml/h. | Drug | Ascorbic acid group |
| SalineAlso: saline (medicine)After participants underwent induction of anesthesia, 50 ml of saline was used and pumped using a micro pump at a rate of 25 ml/h. | Drug | Control comparator group |
Primary outcome
incidence of postoperative pulmonary complications
Time frame: About 10 days
This will be assessed using the Postoperative Pulmonary Complications Score, which ranges from 0 to 5, with a score of ≥3 being considered positive for postoperative pulmonary complications. It was assessed every day before discharge and the highest score that occurred was recorded.
12 secondary outcomes
Neuron-specific enolase levels
Time frame: Post operative day 1
Length of hospitalization
Time frame: About 10 days
Oxygenation index
Time frame: One hour postoperative
Pain scores
Time frame: 1 day, 3 days, 7 days postoperative
pulmonary compliance
Time frame: Last hour of surgery.
Interleukin-6
Time frame: 1 day, 3 days, 7 days postoperative
superoxide dismutase (SOD)
Time frame: 1 day, 3 days, 7 days postoperative
body temperature
Time frame: 1 day, 3 days, 7 days postoperative
blood pressure
Time frame: About 10 days
Brain-specific cardiolipin
Time frame: About 3 days
neutrophil
Time frame: About 10 days
C-reactive protein
Time frame: 1 day, 3 days, 7 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Background: PubMed 18671633Sogame LC, Vidotto MC, Jardim JR, Faresin SM. Incidence and risk factors for postoperative pulmonary complications in elective intracranial surgery. J Neurosurg. 2008 Aug;109(2):222-7. doi: 10.3171/JNS/2008/109/8/0222.
- Background: PubMed 23581713May JM, Harrison FE. Role of vitamin C in the function of the vascular endothelium. Antioxid Redox Signal. 2013 Dec 10;19(17):2068-83. doi: 10.1089/ars.2013.5205. Epub 2013 May 29.
- Background: PubMed 33297491Holford P, Carr AC, Jovic TH, Ali SR, Whitaker IS, Marik PE, Smith AD. Vitamin C-An Adjunctive Therapy for Respiratory Infection, Sepsis and COVID-19. Nutrients. 2020 Dec 7;12(12):3760. doi: 10.3390/nu12123760.
- Background: PubMed 32848365Wang D, Wang M, Zhang H, Zhu H, Zhang N, Liu J. Effect of Intravenous Injection of Vitamin C on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery: A Double-Blind, Randomized Trial. Drug Des Devel Ther. 2020 Aug 11;14:3263-3270. doi: 10.2147/DDDT.S254150. eCollection 2020.
- 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
Related trials for Ascorbic Acid
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Recruiting
Effect of Rutin and Vitamin C on Outcomes in Adults With Sepsis Admitted to the Intensive Care Unit
Sepsis
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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.
Dong Wang, M.D principal investigator
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic acid and Saline in people with Ascorbic Acid and Neurosurgical Procedures, run by Qianfoshan Hospital 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 4 inclusion and 9 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 20 May 2024. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dong Wang, M.D (18353173516, ngbaise@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative pulmonary complications (time frame: About 10 days). 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 NCT06421688, which also lists 5 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 20 May 2024.