Contrast-induced NephropathyNCT03391830
Effects Of Combination Therapy Of Statin And Ascorbic Acid For Prevention Of Contrast-Induced Nephropathy
A study testing Atorvastatin-Ascorbic acid in people with Contrast-induced Nephropathy and Statin, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate the benefit for statin use in prevention of of CI-AKI after computed tomography urogram (CTU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Nephropathy, Statin, Ascorbic Acid
- What is being tested?
- Atorvastatin-Ascorbic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 1 Jan 2020
- Phase
- Interventional
- 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
- Planned computed tomography urogram (CTU)
- Statin naive, or not on statin treatment for at least 14 day
Who cannot join
- History of liver disease or elevated serum transaminases
- History of rhabdomyolysis or elevated creatinine kinase
- History of iodinated CM use within 14 days before randomization
- History of N-acetylcysteine, metformin or nonsteroidal anti-inflammatory drugs use within 48 hours of the procedure.
- History of hypersensitivity reaction to contrast media
- Pregnancy or lactation
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- Acute renal failure
- End-stage renal disease requiring dialysis
- Cardiogenic shock or pulmonary edema
- Multiple myeloma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Combination Therapy Of Statin And Ascorbic Acid For Prevention Of Contrast-Induced Nephropathy. Randomised Controlled Study
To evaluate the benefit for statin use in prevention of of CI-AKI after computed tomography urogram (CTU).
- Conditions
- Contrast-induced Nephropathy, Statin, Ascorbic Acid, AKI
- Being tested
- Atorvastatin-Ascorbic acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin-Ascorbic acidDrug
atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin-Ascorbic acid | Active comparator | atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg Receives: Drug: Atorvastatin-Ascorbic acid |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast Induced-Acute Kidney Injury
Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure.
Measured: 3 days
Secondary outcomes (1)
long-term Renal function by estimated GFR
measured in ml/min/1.73m2
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start15 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced NephropathyStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelwahab Hashem, Mansoura University
- Investigators
- Yasser Othman, MD, Study chair, Urology and nephrology center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391830
- Sponsor's protocol ID
- CN PREVENTION
- Status last verified
- May 2018
- First submitted
- 30 Dec 2017
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Combination Therapy Of Statin And Ascorbic Acid For Prevention Of Contrast-Induced Nephropathy. Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03391830
- Acronym / sponsor ID
- CN PREVENTION
- Conditions
- Contrast-induced Nephropathy, Statin, Ascorbic Acid, AKI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 5 Jan 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.
To evaluate the benefit for statin use in prevention of of CI-AKI after computed tomography urogram (CTU).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin-Ascorbic acid | Active comparator | Drug: Atorvastatin-Ascorbic acidatorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned computed tomography urogram (CTU)
- Statin naive, or not on statin treatment for at least 14 day
Key exclusion criteria (10 listed)
- History of liver disease or elevated serum transaminases
- History of rhabdomyolysis or elevated creatinine kinase
- History of iodinated CM use within 14 days before randomization
- History of N-acetylcysteine, metformin or nonsteroidal anti-inflammatory drugs use within 48 hours of the procedure.
- History of hypersensitivity reaction to contrast media
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 |
|---|---|---|
| Atorvastatin-Ascorbic acidatorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg | Drug | Atorvastatin-Ascorbic acid |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Contrast Induced-Acute Kidney Injury
Time frame: 3 days
Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure.
1 secondary outcome
long-term Renal function by estimated GFR
Time frame: 30 days
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 12 Jan 2021.
- Individual participant dataSharing planned: No
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Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
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ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
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Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
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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.
Yasser Othman, MD study chair
Urology and nephrology center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin-Ascorbic acid in people with Contrast-induced Nephropathy and Statin, run by Mansoura 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 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: finished, as of the sponsor's last update on 12 Jan 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 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.
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?
Contrast Induced-Acute Kidney Injury (time frame: 3 days). 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 12 Jan 2021.