Primary Graft DysfunctionPhase 2NCT04505878
Perioperative Vitamin C Lung Transplant
A Phase 2 study testing Vitamin C in people with Primary Graft Dysfunction and Lung Transplant; Complications, run by University of Wisconsin, Madison.
Trial summary
This study is being done to determine if parenterally administered ascorbic acid (Vitamin C) given at the time of lung transplant is safe. Vitamin C may be an effective intervention towards primary graft dysfunction (PGD). The study will enroll 69 participants who consent to the intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Graft Dysfunction, Lung Transplant; Complications
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is scheduled for lung transplantation
Who cannot join
- Non-English speaking
- Subject is known or believed to be pregnant
- Subject is a prisoner.
- Subject has impaired decision-making capacity.
- Subject has known allergy to vitamin C.
- Subject has history of nephrolithiasis, oxalosis or hyperoxaluria. (Cystic Fibrosis patients are at risk of occult oxalosis / hyperoxaluria, therefore they will also be excluded from the study.)
Show all 14Show fewer
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Sickle cell anemia
- Heredity hemochromatosis
- Baseline creatinine >2 mg/dL or any current kidney injury
- Weight <60 kg
- Vitamin C supplement use or administration (including HAT therapy) within the last month prior to transplantation
- Current enrolment in another research study
- Not suitable for study participation due to other reasons at the discretion of the investigators.
About this study
Official title: Vitamin C: Assessing Safety After Lung Transplant
This study is being done to determine if parenterally administered ascorbic acid (Vitamin C) given at the time of lung transplant is safe. Vitamin C may be an effective intervention towards primary graft dysfunction (PGD). The study will enroll 69 participants who consent to the intervention. Participants who do not consent to the intervention will be treated according to standard-of-care, but may choose to be consented to have their data retrospectively reviewed. Based on our consent rate, this group may include 40-70 participants. Participants will be on study for up to 12 months.
Read the detailed description
PGD is a frequent and severe outcome that impacts both short- and long-term outcomes after lung transplantation. Major pathophysiologic contributors include ischemia and reperfusion injury, mitochondrial dysfunction and endothelial failure. No directed therapy exists. Vitamin C is a first-line antioxidant that also acts at the endothelium and mitochondria to decrease permeability and leak, inhibit mitochondrial dysfunction and improve ischemia and reperfusion. When combined with steroids, part of standard care for lung transplant recipients, these effects may be enhanced and synergistically inhibit instigators of patient injury. A pilot trial will ensure safety of this potential intervention and guide future research into this important outcome measure. It will be readily received in the literature.
For the present study, vitamin C will be administered parenterally at a dose of 1,500 mg every 6 hours, a dose that is widely accepted and used in other clinical contexts where the drug is studied, such as sepsis. This will predictably reconstitute levels and achieve supratherapeutic benefit towards oxidant scavenging, while avoiding the potential pro-oxidant effects seen at exceedingly high doses. To this end, the investigators will exclude patients where the standard dosing of vitamin C will exceed 100 mg/kg/day (excluding patients <60 kg). Dosing will continue through post-operative day (POD) 3 to effectively assess for the impact of vitamin C on PGD.
Primary Objectives
- To assess whether parenterally administered ascorbic acid (vitamin C) is safe in the lung transplant population
- To estimate adherence to ascorbic acid administration protocol in this study population and to identify obstacles to feasibility of future trials using this protocol
Secondary Objectives
- To assess whether parenterally administered ascorbic acid (vitamin C) may decrease the rate and severity of PGD after lung transplant
- To establish the incidence of vitamin C and vitamin B1 (thiamine) deficiencies in the lung transplant population, and the responsiveness of vitamin C levels to our selected parenteral therapy
- To identify interventions that will optimize the post-operative wellbeing of patients receiving lung transplants by decreasing primary graft dysfunction (short and intermediate-to-long term
Stop Criteria
- Anuria x 3-hours
- Moderate, Grade 2 AKI (doubling of baseline creatinine)
- An acute, unexplained hemoglobin drop of >2 mg/dL
- Being tested
- Vitamin C
- Keywords
- Vitamin C
- Medical subject headings
- Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called ascorbic acid
Vitamin C is a first-line antioxidant that directly scavenges free radicals, inhibits reactive oxygen species (ROS) producing enzymes and recovers other cellular antioxidants
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C Arm | Experimental | Ascorbic Acid will be administered at a dose of 1500 mg in 100 mL of saline over 30 minutes intravenously once every 6 hours for a total of 72 hours Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Kidney Injury Post Operative Day (POD) 1
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Measured: Post Operative Day 1
Incidence and Severity of Kidney Injury POD 2
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Measured: Post Operative Day 2
Incidence and Severity of Kidney Injury POD 3
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Measured: Post Operative Day 3
Incidence and Severity of Kidney Injury POD 4
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Measured: Post Operative Day 4
Incidence and Severity of Kidney Injury POD 7
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Measured: Post Operative Day 7
Incidence of New Dialysis Initiation
Measured: up to Post Operative Day 7
Secondary outcomes (22)
Participant Vitamin C Levels
Measured: Baseline, Post Operative Day 1, Post Operative Day 2, Post Operative Day 3
Participant Thiamine Levels
Measured: Baseline, Post Operative Day 1, Post Operative Day 2, Post Operative Day 3
Incidence of Primary Graft Dysfunction (PGD)
Primary Graft Dysfunction is defined as chest x-ray (CXR)-infiltrates with or without depressed oxygenation function, assessed by the "PF-Ratio," which is the PaO2 / FiO2.
Measured: up to Post Operative Day 7
Incidence and Severity of PGD on POD 3
Primary Graft Dysfunction is defined as chest x-ray (CXR)-infiltrates with or without depressed oxygenation function, assessed by the "PF-Ratio," which is the PaO2 / FiO2. Severity is defined as: PGD Grade 1 = CXR findings and any PF Ratio > 300; PGD Grade 2 = CXR findings and PF Ratio 200-300; and PGD Grade 3 = CXR findings and PF Ratio <200.
Measured: Post Operative Day 3
Tacrolimus Levels
Measured: Post Operative Days 2, 3, 4, and 7
Tacrolimus Doses
Measured: Post Operative Days 4 and 7
Post-Operative Well Being: Mortality
Measured: at Post Operative Day 30 and Post Operative Day 90 via chart review
Post-Operative Well Being: Atrial Fibrillation
Measured: up to Post Operative Day 7
Post-Operative Well Being: ICU Length of Stay
Measured: up to Post Operative Day 30 (chart review)
Post-Operative Well Being: Hospital Length of Stay
Measured: up to Post Operative Day 90 (chart review)
Post-Operative Well Being: Nadir Cardiac Index
Measured: up to 72 hours post op
Post-Operative Well Being: Peak Pulmonary Artery Systolic Pressure
Measured: up to 72 hours post op
Post-Operative Well Being: Peak Pulmonary Artery Diastolic Pressure
Measured: up to 72 hours post op
Post-Operative Well Being: Duration of Inotrope Need
Measured: up to 72 hours post op
Post-Operative Well Being: Duration of Vasopressor
Measured: up to 72 hours post op
Post-Operative Well Being: Total Dose of Vasopressor
Measured: up to 72 hours post op
Post-Operative Well Being: Daily Crystalloid Volume
for 0-24h, 24-48h and 48-72h; total volume balance at 72-hours
Measured: up to 72 hours post op
Post-Operative Well Being: Daily Blood Product Transfusion Volume
for 0-24h, 24-48h and 48-72h; total volume balance at 72-hours
Measured: up to 72 hours post op
Post-Operative Well Being: Daily Chest Tube Output Volume
for 0-24h, 24-48h and 48-72h; total volume balance at 72-hours
Measured: up to 72 hours post op
Post-Operative Well Being: Duration of Post-Operative Mechanical Ventilation
Measured: up to Post Operative Day 7
Post-Operative Well Being: PaO2 / FIO2 ratios
The PF Ratio assesses the lungs' ability to oxygenate the blood. It is defined as the ratio of the partial pressure of oxygen in the arteries (PaO2 in mmHg) to the fractional inspired oxygen content from the ventilator (FiO2 in %).
Measured: Post Operative Day 1, Post Operative Day 2, Post Operative Day 3
Post-Operative Well Being: Time to Clearance of Lactate
"Clearance" is defined as a lactate <1 mmol/L.
Measured: up to Post Operative Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study startApr 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Decided not to proceed with study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Graft DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot single-arm unblinded trial to assess whether parenterally administered ascorbic acid (vitamin C) is safe in the lung transplant population.The investigators will not randomize or control; a retrospective cohort of participants not treated with vitamin C will be reviewed from 2015-2020. Those participants who decline the intervention will have the choice to consent to having their data be considered as part of the (non-retrospective) controls and be considered in our statistical analysis for outcomes, including analysis between this group and the historical controls. All participants who consent will be administered the therapy and participants will be evaluated via an intention-to-treat analysis.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Micah Long, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505878
- Sponsor's protocol ID
- 2020-0503
- Other IDs
- A530900, SMPH/ANESTHESIOLOGY, Protocol Version 0.05
- Status last verified
- Apr 2023
- First submitted
- 5 Aug 2020
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting Dr. Micah Long, the Principal Investigator of this study.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C: Assessing Safety After Lung Transplant
- ClinicalTrials.gov ID
- NCT04505878
- Acronym / sponsor ID
- 2020-0503
- Keywords
- Vitamin C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided not to proceed with study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Aug 2020 (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.
This study is being done to determine if parenterally administered ascorbic acid (Vitamin C) given at the time of lung transplant is safe. Vitamin C may be an effective intervention towards primary graft dysfunction (PGD). The study will enroll 69 participants who consent to the intervention. Participants who do not consent to the intervention will be treated according to standard-of-care, but may choose to be consented to have their data retrospectively reviewed. Based on our consent rate, this group may include 40-70 participants. Participants will be on study for up to 12 months.
Detailed description
PGD is a frequent and severe outcome that impacts both short- and long-term outcomes after lung transplantation. Major pathophysiologic contributors include ischemia and reperfusion injury, mitochondrial dysfunction and endothelial failure. No directed therapy exists. Vitamin C is a first-line antioxidant that also acts at the endothelium and mitochondria to decrease permeability and leak, inhibit mitochondrial dysfunction and improve ischemia and reperfusion. When combined with steroids, part of standard care for lung transplant recipients, these effects may be enhanced and synergistically inhibit instigators of patient injury. A pilot trial will ensure safety of this potential intervention and guide future research into this important outcome measure. It will be readily received in the literature.
For the present study, vitamin C will be administered parenterally at a dose of 1,500 mg every 6 hours, a dose that is widely accepted and used in other clinical contexts where the drug is studied, such as sepsis. This will predictably reconstitute levels and achieve supratherapeutic benefit towards oxidant scavenging, while avoiding the potential pro-oxidant effects seen at exceedingly high doses. To this end, the investigators will exclude patients where the standard dosing of vitamin C will exceed 100 mg/kg/day (excluding patients <60 kg). Dosing will continue through post-operative day (POD) 3 to effectively assess for the impact of vitamin C on PGD.
Primary Objectives
- To assess whether parenterally administered ascorbic acid (vitamin C) is safe in the lung transplant population
- To estimate adherence to ascorbic acid administration protocol in this study population and to identify obstacles to feasibility of future trials using this protocol
Secondary Objectives
- To assess whether parenterally administered ascorbic acid (vitamin C) may decrease the rate and severity of PGD after lung transplant
- To establish the incidence of vitamin C and vitamin B1 (thiamine) deficiencies in the lung transplant population, and the responsiveness of vitamin C levels to our selected parenteral therapy
- To identify interventions that will optimize the post-operative wellbeing of patients receiving lung transplants by decreasing primary graft dysfunction (short and intermediate-to-long term
Stop Criteria
- Anuria x 3-hours
- Moderate, Grade 2 AKI (doubling of baseline creatinine)
- An acute, unexplained hemoglobin drop of >2 mg/dL
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot single-arm unblinded trial to assess whether parenterally administered ascorbic acid (vitamin C) is safe in the lung transplant population.The investigators will not randomize or control; a retrospective cohort of participants not treated with vitamin C will be reviewed from 2015-2020. Those participants who decline the intervention will have the choice to consent to having their data be considered as part of the (non-retrospective) controls and be considered in our statistical analysis for outcomes, including analysis between this group and the historical controls. All participants who consent will be administered the therapy and participants will be evaluated via an intention-to-treat analysis.
| Arm | Type | Receives |
|---|---|---|
| Vitamin C Arm | Experimental | Drug: Vitamin CAscorbic Acid will be administered at a dose of 1500 mg in 100 mL of saline over 30 minutes intravenously once every 6 hours for a total of 72 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participant is scheduled for lung transplantation
Key exclusion criteria (14 listed)
- Non-English speaking
- Subject is known or believed to be pregnant
- Subject is a prisoner.
- Subject has impaired decision-making capacity.
- Subject has known allergy to vitamin C.
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 |
|---|---|---|
| Vitamin CAlso: ascorbic acidVitamin C is a first-line antioxidant that directly scavenges free radicals, inhibits reactive oxygen species (ROS) producing enzymes and recovers other cellular antioxidants | Drug | Vitamin C Arm |
Primary outcome
Incidence and Severity of Kidney Injury Post Operative Day (POD) 1
Time frame: Post Operative Day 1
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Incidence and Severity of Kidney Injury POD 2
Time frame: Post Operative Day 2
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Incidence and Severity of Kidney Injury POD 3
Time frame: Post Operative Day 3
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Incidence and Severity of Kidney Injury POD 4
Time frame: Post Operative Day 4
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Incidence and Severity of Kidney Injury POD 7
Time frame: Post Operative Day 7
The primary endpoint is the safety of the vitamin C intervention. This will be measured by the incidence and severity of kidney injuries on POD 1, POD 2, POD 3, POD 4, and POD 7. Acute kidney injury (AKI) is defined as any creatinine (Cr) that is 1.5-times the participant's baseline / immediate preoperative creatinine. Severity escalates with increasing ratios: Mild, stage 1 AKI (Cr 1.5-1.99x baseline); Moderate, stage 2 AKI (Cr 2-2.9x baseline); and Severe, stage 3 AKI (Cr >3x baseline or any initiation of dialysis).
Incidence of New Dialysis Initiation
Time frame: up to Post Operative Day 7
22 secondary outcomes
Participant Vitamin C Levels
Time frame: Baseline, Post Operative Day 1, Post Operative Day 2, Post Operative Day 3
Participant Thiamine Levels
Time frame: Baseline, Post Operative Day 1, Post Operative Day 2, Post Operative Day 3
Incidence of Primary Graft Dysfunction (PGD)
Time frame: up to Post Operative Day 7
Incidence and Severity of PGD on POD 3
Time frame: Post Operative Day 3
Tacrolimus Levels
Time frame: Post Operative Days 2, 3, 4, and 7
Tacrolimus Doses
Time frame: Post Operative Days 4 and 7
Post-Operative Well Being: Mortality
Time frame: at Post Operative Day 30 and Post Operative Day 90 via chart review
Post-Operative Well Being: Atrial Fibrillation
Time frame: up to Post Operative Day 7
Post-Operative Well Being: ICU Length of Stay
Time frame: up to Post Operative Day 30 (chart review)
Post-Operative Well Being: Hospital Length of Stay
Time frame: up to Post Operative Day 90 (chart review)
Post-Operative Well Being: Nadir Cardiac Index
Time frame: up to 72 hours post op
Post-Operative Well Being: Peak Pulmonary Artery Systolic Pressure
Time frame: up to 72 hours post op
Post-Operative Well Being: Peak Pulmonary Artery Diastolic Pressure
Time frame: up to 72 hours post op
Post-Operative Well Being: Duration of Inotrope Need
Time frame: up to 72 hours post op
Post-Operative Well Being: Duration of Vasopressor
Time frame: up to 72 hours post op
Post-Operative Well Being: Total Dose of Vasopressor
Time frame: up to 72 hours post op
Post-Operative Well Being: Daily Crystalloid Volume
Time frame: up to 72 hours post op
Post-Operative Well Being: Daily Blood Product Transfusion Volume
Time frame: up to 72 hours post op
Post-Operative Well Being: Daily Chest Tube Output Volume
Time frame: up to 72 hours post op
Post-Operative Well Being: Duration of Post-Operative Mechanical Ventilation
Time frame: up to Post Operative Day 7
Post-Operative Well Being: PaO2 / FIO2 ratios
Time frame: Post Operative Day 1, Post Operative Day 2, Post Operative Day 3
Post-Operative Well Being: Time to Clearance of Lactate
Time frame: up to Post Operative Day 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: Yes. Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting Dr. Micah Long, the Principal Investigator of this study.
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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.
Micah Long, MD principal investigator
UW School of Medicine and Public Health
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C in people with Primary Graft Dysfunction and Lung Transplant; Complications, run by University of Wisconsin, Madison.
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 1 inclusion and 14 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: withdrawn, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Kidney Injury Post Operative Day (POD) 1 (time frame: Post Operative Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2023.