VasoplegiaEarly Phase 1NCT03744702
Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
A Early Phase 1 study testing Ascorbic Acid in people with Vasoplegia, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a prospective pilot study in which the effects of ascorbic acid administration are investigated in adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass (CPB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasoplegia
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2019to 5 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Undergoing cardiac surgery with the use of cardiopulmonary bypass
- Undergoing myectomy or valve replacement/repair
Who cannot join
- Coronary artery bypass grafting (CABG)
- Circulatory arrest
- Active infection or sepsis
- Severe hepatic disease or ascites
- Pre-operative renal dysfunction requiring dialysis
- Pre-operative midodrine
- Pre-operative oral or intravenous steroid use
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study for Determining the Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
This is a prospective pilot study in which the effects of ascorbic acid administration are investigated in adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass (CPB). Ascorbic acid (Vitamin C) is an essential cofactor in the biosynthesis of catecholamines, and critically ill patients are known to be ascorbate-deficient. In addition, cardiopulmonary bypass (CPB) decreases ascorbic acid concentrations. Cardiac vasoplegia is the loss of vascular tone despite adequate volume status and cardiac output, occurring commonly in patients after CPB. This necessitates the administration of vasopressors and alternative agents which can have deleterious effects. The administration of ascorbic acid to cardiac surgical patients may improve microcirculatory function, enhance endogenous catecholamine levels and decrease the need for exogenous vasopressor support.
Read the detailed description
- Specific Aims
The investigators aim to determine the feasibility of performing a study that can assess the impact of ascorbic acid administration on the development and severity of cardiac vasoplegia in cardiac surgical patients undergoing procedures at high risk for vasoplegia.
Specific Aim 1: Determine the feasibility of administration of high dose intravenous ascorbic acid in the operative and post-operative environments as well as sample size for a prospective, randomized, placebo controlled study.
Specific Aim 2: Determine baseline ascorbic acid plasma levels in a small cohort of cardiac surgical patients.
Specific Aim 3: Determine the impact of ascorbic acid administration on microvasculature as measured by dark field microscopy.
- Conditions
- Vasoplegia
- Being tested
- Ascorbic Acid
- Keywords
- vasoplegia, cardiac surgery, ascorbic acid
- Medical subject headings
- Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Ascor
Patients will receive IV ascorbic acid.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All patients will receive ascorbic acid as this is a pilot study. Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressor duration in hours
Total duration of vasopressor therapy
Measured: Up to 10 days following surgery
Vasopressor dose
Total dose of vasopressor in norepinephrine equivalents (mcg)
Measured: Up to 10 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start28 Jun 2019
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VasoplegiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica D. Wittwer, M.D., Ph.D., Mayo Clinic
- Investigators
- Erica D Wittwer, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744702
- Sponsor's protocol ID
- 18-003358
- Status last verified
- Mar 2021
- First submitted
- 14 Nov 2018
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wieruszewski PM, Radosevich MA, Nei SD, Kashani KB, Normand SE, Schaff HV, Wittwer ED. Ascorbic acid and microcirculation in cardiothoracic surgery: a pilot feasibility trial and matched cohort study. J Cardiothorac Surg. 2025 May 22;20(1):234. doi: 10.1186/s13019-025-03486-8.
PubMed 40400032
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Determining the Impact of Ascorbic Acid Treatment on the Development and Treatment of Vasodilation in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03744702
- Acronym / sponsor ID
- 18-003358
- Conditions
- Vasoplegia
- Keywords
- vasoplegia, cardiac surgery, ascorbic acid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 16 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.
This is a prospective pilot study in which the effects of ascorbic acid administration are investigated in adult patients undergoing cardiac surgical procedures requiring cardiopulmonary bypass (CPB). Ascorbic acid (Vitamin C) is an essential cofactor in the biosynthesis of catecholamines, and critically ill patients are known to be ascorbate-deficient. In addition, cardiopulmonary bypass (CPB) decreases ascorbic acid concentrations. Cardiac vasoplegia is the loss of vascular tone despite adequate volume status and cardiac output, occurring commonly in patients after CPB. This necessitates the administration of vasopressors and alternative agents which can have deleterious effects. The administration of ascorbic acid to cardiac surgical patients may improve microcirculatory function, enhance endogenous catecholamine levels and decrease the need for exogenous vasopressor support.
Detailed description
- Specific Aims
The investigators aim to determine the feasibility of performing a study that can assess the impact of ascorbic acid administration on the development and severity of cardiac vasoplegia in cardiac surgical patients undergoing procedures at high risk for vasoplegia.
Specific Aim 1: Determine the feasibility of administration of high dose intravenous ascorbic acid in the operative and post-operative environments as well as sample size for a prospective, randomized, placebo controlled study.
Specific Aim 2: Determine baseline ascorbic acid plasma levels in a small cohort of cardiac surgical patients.
Specific Aim 3: Determine the impact of ascorbic acid administration on microvasculature as measured by dark field microscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Ascorbic AcidAll patients will receive ascorbic acid as this is a pilot study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Undergoing cardiac surgery with the use of cardiopulmonary bypass
- Undergoing myectomy or valve replacement/repair
Key exclusion criteria (7 listed)
- Coronary artery bypass grafting (CABG)
- Circulatory arrest
- Active infection or sepsis
- Severe hepatic disease or ascites
- Pre-operative renal dysfunction requiring dialysis
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: AscorPatients will receive IV ascorbic acid. | Drug | Treatment |
Primary outcome
Vasopressor duration in hours
Time frame: Up to 10 days following surgery
Total duration of vasopressor therapy
Vasopressor dose
Time frame: Up to 10 days following surgery
Total dose of vasopressor in norepinephrine equivalents (mcg)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 40400032Wieruszewski PM, Radosevich MA, Nei SD, Kashani KB, Normand SE, Schaff HV, Wittwer ED. Ascorbic acid and microcirculation in cardiothoracic surgery: a pilot feasibility trial and matched cohort study. J Cardiothorac Surg. 2025 May 22;20(1):234. doi: 10.1186/s13019-025-03486-8.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Erica D Wittwer principal investigator
Mayo Clinic
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 in people with Vasoplegia, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 11 Mar 2021. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vasopressor duration in hours (time frame: Up to 10 days following surgery). The study lists 2 primary outcomes in all. 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 NCT03744702, which also lists 1 linked publication.
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 11 Mar 2021.