Cardiothoracic SurgeryPhase 4NCT03639519
A Trial to Assess the Impact of Ascorbic Acid on Cardiac Surgeries Outcomes and Complications''
A Phase 4 study testing Ascorbic Acid 500Mg Chew Tab and Carbonated orange beverage in people with Cardiothoracic Surgery, run by El-Galaa Military Medical Complex at 1 site in Egypt.
Trial summary
this study is evaluating the safety and efficacy of ascorbic acid as a drug that can decrease inflammatory complications post surgical in addition to its impact on decreasing risk of arrhythmia and total opioid administration post operative Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiothoracic Surgery
- What is being tested?
- Ascorbic Acid 500Mg Chew Tab and Carbonated orange beverage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2018to 15 Aug 2019
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective Cardiac surgery
- American Society of Anesthesiologists physical status class I-III
Who cannot join
- Allergy to ascorbic acid
- Asthma
- COPD
- Allergy to opioids
- Previous history of chemical dependence
- Prior cardiac surgery
Show all 10Show fewer
- Known hyperoxaluria
- History of renal calculi
- History of allergic or hypersensitivity reaction to ascorbic acid products
- Currently taking 1 g or more of ascorbic acid supplementation daily
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Galaa Military Medical Complex
Cairo, Sheraton, 11651
Tamer M Ayed, MD
Tamer M Ayed, MD
About this study
Official title: 'A Prospective Randomized Trial to Assess the Impact of Ascorbic Acid on Outcomes and Complications Post Cardiac Surgeries''
this study is evaluating the safety and efficacy of ascorbic acid as a drug that can decrease inflammatory complications post surgical in addition to its impact on decreasing risk of arrhythmia and total opioid administration post operative
Read the detailed description
The study will include two arm of patients who are scheduled for elective cardiac surgery, either coronary artery bypass grafting (CABG) or Valvular replacement First arm: Patients will take 2 g orally ascorbic acid effervescent tablets the night before cardiac surgery, then 1 g twice daily for 5 days after surgery in addition to their traditional medical care. Second arm: will not be given ascorbic acid , instead a placebo 9orange carbonated beverage) will be used, and will be given the rest of traditional medical care provided to the first arm. Inflammatory markers C- reactive protein (CRP), erythrocyte sedimentation rate (ESR) and differential total leukocytic count (TLC), serum urea and creatinine, ALT, AST, CK-mb, CK-Total, aPTT, INR, Hemoglobin, platelet count, will be assessed on day 0, 1,2,4,6 postoperative in both arms.
- Conditions
- Cardiothoracic Surgery
- Being tested
- Ascorbic Acid 500Mg Chew Tab, Carbonated orange beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic Acid 500Mg Chew TabDrug
Ascorbic acid will be administered at the night before surgery and will be continued for five days
Carbonated orange beverageOther
The carbonated orange beverage will be administered at the night before surgery and will be continued for five days
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic acid | Experimental | Patients will take 2 g orally ascorbic acid effervescent tablets the night before cardiac surgery, then 1 g twice daily for 5 days after surgery in addition to their traditional medical care. Receives: Drug: Ascorbic Acid 500Mg Chew Tab |
| Placebo group | Placebo comparator | will not be given ascorbic acid , instead a placebo will be used, and will be given the rest of traditional medical care provided to the first arm. Inflammatory markers (CRP, ESR and differential TLC), serum urea and creatinine, ALT, AST, CK-mb, CK-Total, aPTT, INR, Hemoglobin, platelet count, will be assessed on day 0, 1,2,4,6 postoperative in both arms. Receives: Other: Carbonated orange beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of arrhythmia post operative
assessing risk of AF post surgical using ECG
Measured: 7 days post operative
pain management
Evaluating cumulative dose of opioid administered within ICU stay in the two groups
Measured: 2 days post operative
wound healing
assessment of wound inflammation and infection risk using ASEPSIS score (a scoring system to assess wound healing and evaluate the presence of infection, a score between 10 to 20 means disturbed healing, >20 points means infected wound, >30 means moderate to sever infection)
Measured: 30 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start15 Apr 2018
- Primary completion15 Apr 2019 (estimated)
- Study completion15 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiothoracic SurgeryStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- El-Galaa Military Medical Complex
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639519
- Sponsor's protocol ID
- GMMC-RC18-2
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'A Prospective Randomized Trial to Assess the Impact of Ascorbic Acid on Outcomes and Complications Post Cardiac Surgeries''
- ClinicalTrials.gov ID
- NCT03639519
- Acronym / sponsor ID
- GMMC-RC18-2
- Conditions
- Cardiothoracic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- El-Galaa Military Medical ComplexOther government
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Apr 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 21 Aug 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 study is evaluating the safety and efficacy of ascorbic acid as a drug that can decrease inflammatory complications post surgical in addition to its impact on decreasing risk of arrhythmia and total opioid administration post operative
Detailed description
The study will include two arm of patients who are scheduled for elective cardiac surgery, either coronary artery bypass grafting (CABG) or Valvular replacement First arm: Patients will take 2 g orally ascorbic acid effervescent tablets the night before cardiac surgery, then 1 g twice daily for 5 days after surgery in addition to their traditional medical care. Second arm: will not be given ascorbic acid , instead a placebo 9orange carbonated beverage) will be used, and will be given the rest of traditional medical care provided to the first arm. Inflammatory markers C- reactive protein (CRP), erythrocyte sedimentation rate (ESR) and differential total leukocytic count (TLC), serum urea and creatinine, ALT, AST, CK-mb, CK-Total, aPTT, INR, Hemoglobin, platelet count, will be assessed on day 0, 1,2,4,6 postoperative in both arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascorbic acid | Experimental | Drug: Ascorbic Acid 500Mg Chew TabPatients will take 2 g orally ascorbic acid effervescent tablets the night before cardiac surgery, then 1 g twice daily for 5 days after surgery in addition to their traditional medical care. |
| Placebo group | Placebo comparator | Other: Carbonated orange beveragewill not be given ascorbic acid , instead a placebo will be used, and will be given the rest of traditional medical care provided to the first arm. Inflammatory markers (CRP, ESR and differential TLC), serum urea and creatinine, ALT, AST, CK-mb, CK-Total, aPTT, INR, Hemoglobin, platelet count, will be assessed on day 0, 1,2,4,6 postoperative in both arms. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective Cardiac surgery
- American Society of Anesthesiologists physical status class I-III
Key exclusion criteria (10 listed)
- Allergy to ascorbic acid
- Asthma
- COPD
- Allergy to opioids
- Previous history of chemical dependence
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 Acid 500Mg Chew TabAscorbic acid will be administered at the night before surgery and will be continued for five days | Drug | Ascorbic acid |
| Carbonated orange beverageThe carbonated orange beverage will be administered at the night before surgery and will be continued for five days | Other | Placebo group |
Primary outcome
Risk of arrhythmia post operative
Time frame: 7 days post operative
assessing risk of AF post surgical using ECG
pain management
Time frame: 2 days post operative
Evaluating cumulative dose of opioid administered within ICU stay in the two groups
wound healing
Time frame: 30 days post operative
assessment of wound inflammation and infection risk using ASEPSIS score (a scoring system to assess wound healing and evaluate the presence of infection, a score between 10 to 20 means disturbed healing, >20 points means infected wound, >30 means moderate to sever infection)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ascorbic Acid 500Mg Chew Tab and Carbonated orange beverage in people with Cardiothoracic Surgery, run by El-Galaa Military Medical Complex at 1 site in Egypt.
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 10 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 21 Aug 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Tamer M Ayed, MD (01006045615, Tamerayed70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of arrhythmia post operative (time frame: 7 days post operative). The study lists 3 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 21 Aug 2018.