Acute Kidney InjuryPhase 4NCT03921099
Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty
A Phase 4 study testing Ascorbic Acid in people with Acute Kidney Injury, run by Ain Shams University at 1 site in Egypt.
Trial summary
A Randomized controlled trial aiming to investigate whether ascorbic acid has a role in preventing vancomycin induced nephrotoxicity or not in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2019to Sep 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who are critically ill and with MRSA infection suspection.
Who cannot join
- Pregnancy or breast feeding.
- Known allergy to either vancomycin or ascorbic acid.
- Base line serum creatinine ≥2mg/dl.
- Patients receiving other nephrotoxic drug (e.g., aminoglycosides, amphotericin B, cisplatin or calcinurine inhibitors).
- Anticepated administration of contrast medium within 7 days.
- Patients suffering from some underlying diseases (e.g., cancer, HIV infection, systemic lupus erythematoses,or urinary tract stones).
- Unlikelyhood of receiving the study medications for at least 72 hours
Trial locations and contacts
1 site in 1 country.
Naglaa S Bazan, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo university hospitals
Cairo, 11562
Critical care department Cairo university Hopsitals
About this study
Official title: Evaluation of the Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicity
A Randomized controlled trial aiming to investigate whether ascorbic acid has a role in preventing vancomycin induced nephrotoxicity or not in critically ill patients.
Read the detailed description
Critically ill patients who have gram positive infection (MRSA) and need vancomycin will be assigned randomly into two groups. The first group will be given vancomycin intravenous only (15-20 mg/kg) every 8-12 hours , while the second group will take vancomycin intravenous (15-20 mg/kg) every 8-12 hours plus ascorbic acid 1 gram twice daily orally just before the vancomycin administration by half an hour. Patients will be monitored for one week where serum creatinine, BUN, urine output, trough level will be measured. Acute kidney injury will be determined according to RIFLE criteria.
- Conditions
- Acute Kidney Injury
- Being tested
- Ascorbic Acid
- Medical subject headings
- Acute Kidney Injury
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
ascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin only | No intervention | Vancomycin 15-20mg/kg intravenous every 8-12 hours. |
| Vancomycin +Ascorbic acid | Experimental | Vancomycin 15-20mg/kg intravenous every 8-12 hours. Ascorbic acid 1gm every 12 hours orally just before vancomycin by half an hour for seven days. Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nephrotoxicty
Incidence of nephrotoxicty will be described according to RIFLE criteria
Measured: one week
Secondary outcomes (1)
28 days Mortality
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start17 Jan 2019
- Primary completionJul 2020 (estimated)
- Study completionSep 2020 (estimated)
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 Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Hesham Ali, Ain Shams University
- Investigators
- Nagwa A Sabry, PhD, Study director, Ain Shams UniversitySara M Shaheen, PhD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921099
- Sponsor's protocol ID
- 208
- Status last verified
- Jan 2020
- First submitted
- 16 Apr 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hesham El-Sherazy N, Samir Bazan N, Mahmoud Shaheen S, A Sabri N. Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial. F1000Res. 2021 Sep 16;10:929. doi: 10.12688/f1000research.55619.1. eCollection 2021.
PubMed 34621519
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicity
- ClinicalTrials.gov ID
- NCT03921099
- Acronym / sponsor ID
- 208
- Conditions
- Acute Kidney Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 19 Apr 2019 (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.
A Randomized controlled trial aiming to investigate whether ascorbic acid has a role in preventing vancomycin induced nephrotoxicity or not in critically ill patients.
Detailed description
Critically ill patients who have gram positive infection (MRSA) and need vancomycin will be assigned randomly into two groups. The first group will be given vancomycin intravenous only (15-20 mg/kg) every 8-12 hours , while the second group will take vancomycin intravenous (15-20 mg/kg) every 8-12 hours plus ascorbic acid 1 gram twice daily orally just before the vancomycin administration by half an hour. Patients will be monitored for one week where serum creatinine, BUN, urine output, trough level will be measured. Acute kidney injury will be determined according to RIFLE criteria.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin only | No intervention | –Vancomycin 15-20mg/kg intravenous every 8-12 hours. |
| Vancomycin +Ascorbic acid | Experimental | Drug: Ascorbic AcidVancomycin 15-20mg/kg intravenous every 8-12 hours. Ascorbic acid 1gm every 12 hours orally just before vancomycin by half an hour for seven days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults who are critically ill and with MRSA infection suspection.
Key exclusion criteria (7 listed)
- Pregnancy or breast feeding.
- Known allergy to either vancomycin or ascorbic acid.
- Base line serum creatinine ≥2mg/dl.
- Patients receiving other nephrotoxic drug (e.g., aminoglycosides, amphotericin B, cisplatin or calcinurine inhibitors).
- Anticepated administration of contrast medium within 7 days.
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 Cascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin. | Drug | Vancomycin +Ascorbic acid |
Primary outcome
Incidence of nephrotoxicty
Time frame: one week
Incidence of nephrotoxicty will be described according to RIFLE criteria
1 secondary outcome
28 days Mortality
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Derived from this study: PubMed 34621519Hesham El-Sherazy N, Samir Bazan N, Mahmoud Shaheen S, A Sabri N. Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial. F1000Res. 2021 Sep 16;10:929. doi: 10.12688/f1000research.55619.1. eCollection 2021.
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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.
Naglaa S Bazan, PhD contact
Nagwa A Sabry, PhD study director
Ain Shams University
Sara M Shaheen, PhD study director
Ain Shams University
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 in people with Acute Kidney Injury, run by Ain Shams University 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 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2020. 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. 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 Nouran H Elsherazy, Bachelor (+201224959630, Nouran_elsherazy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of nephrotoxicty (time frame: one week). 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 NCT03921099, 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 10 Jan 2020.