Contrast-induced NephropathyPhase 2CINNCT03867994
Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy.
A Phase 2 study testing Atorvastatin, Carvedilol and saline in people with Contrast-induced Nephropathy, run by rabab ahmed mohamed.
Trial summary
This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Contrast-induced Nephropathy
- What is being tested?
- Atorvastatin, Carvedilol and saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 15 May 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 70 years.
- Serum creatinine ≤ 1.5 mg/dL.
- Using a moderate dose of atorvastatin (40 mg or equivalent dose of other statins).
- Moderate to high-risk for CIN.
Who cannot join
- Patients suffering from ST-segment elevation myocardial infarction (STEMI)
- Patients need for immediate cardiac catheterization
- Elevated liver enzymes (Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) three times the upper limit of normal).
- Active infection.
- Any contraindication to carvedilol, or atorvastatin.
- Patients on regular use of vitamins, minerals.
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- Using medication with antioxidant properties e.g., beta-carotene, vitamin E, vitamin C, selenium, theophylline or N-acetyl cysteine 7 days prior to CC.
- Hemodynamically unstable patients (defined as abnormal or unstable blood pressure, especially hypotension (blood pressure less than 90/60 mm Hg).
- Patients who required dialysis.
- Pregnancy.
- Using of carvedilol in the past three months.
- Using a nephrotoxic agent in the past 48 hours or exposure to a contrast agent in the past 7 days prior to cardiac catheterization.
About this study
Official title: Comparison of Carvedilol and Atorvastatin for Prevention of Contrast-Induced Nephropathy After Cardiac Catheterization
This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.
Read the detailed description
This study enrolled 150 patients planned for CC, and randomly assigned for one of the three groups. Group (A)include 49 patients who received two atorvastatin dose 80 mg 12 hours before CC and 40 mg just before CC. Group (B) include 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continue for 24hrs after the day of CC, Group (C) include 47 patients who only hydrated with saline. All included patients were hydrated with saline intravenous 0.9 sodium chloride (NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. Serum creatinine(Scr), blood urea nitrogen (BUN) and estimated glomerular filtration rate were evaluated at the baseline and after 48 from CC. Serum neutrophil-associated lipocalin (NGAL) was evaluated after 4 hours from CC.
- Conditions
- Contrast-induced Nephropathy
- Being tested
- Atorvastatin, Carvedilol, saline
- Keywords
- Cardiac catheterization, carvedilol, atorvastatin.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
CarvedilolDrug
salineDrug
Also called 0.9%NaCl
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | included 49 patients who received high dose statin (80 mg atorvastatin) 12 hours before CC and 40 mg just before CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. Receives: Drug: Atorvastatin; Drug: saline |
| Group (B) | Experimental | included 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continued for 24 hours after the CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. Receives: Drug: Carvedilol; Drug: saline |
| Group (C) | Experimental | included 47 patients who did not receive any medications but only hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of contrast induced nephropathy
CIN :(defined as absolute rise in the baseline serum creatinine concentration by 0.5 mg/dL after 48 hours from CC).
Measured: 1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure.
Secondary outcomes (1)
Estimated Glomerular filtration rate (eGFR)
Cockcroft-Gault equation was used to calculate (eGFR)
Measured: on admission, and re-calculated 48 hours post CC using
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start1 Feb 2016
- Primary completion15 May 2017
- Study completion15 May 2017
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- rabab ahmed mohamed
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, rabab ahmed mohamed, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867994
- Sponsor's protocol ID
- beta-blockers and statins
- Acronym
- CIN
- Status last verified
- Mar 2019
- First submitted
- 14 Jan 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All medical history included medication and disease, in addition to our study outcomes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Carvedilol and Atorvastatin for Prevention of Contrast-Induced Nephropathy After Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT03867994
- Acronym / sponsor ID
- CIN / beta-blockers and statins
- Conditions
- Contrast-induced Nephropathy
- Keywords
- Cardiac catheterization, carvedilol, atorvastatin.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- rabab ahmed mohamedUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 8 Mar 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.
This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.
Detailed description
This study enrolled 150 patients planned for CC, and randomly assigned for one of the three groups. Group (A)include 49 patients who received two atorvastatin dose 80 mg 12 hours before CC and 40 mg just before CC. Group (B) include 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continue for 24hrs after the day of CC, Group (C) include 47 patients who only hydrated with saline. All included patients were hydrated with saline intravenous 0.9 sodium chloride (NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. Serum creatinine(Scr), blood urea nitrogen (BUN) and estimated glomerular filtration rate were evaluated at the baseline and after 48 from CC. Serum neutrophil-associated lipocalin (NGAL) was evaluated after 4 hours from CC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Drug: Atorvastatin, Drug: salineincluded 49 patients who received high dose statin (80 mg atorvastatin) 12 hours before CC and 40 mg just before CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. |
| Group (B) | Experimental | Drug: Carvedilol, Drug: salineincluded 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continued for 24 hours after the CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. |
| Group (C) | Experimental | Drug: salineincluded 47 patients who did not receive any medications but only hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged between 18 and 70 years.
- Serum creatinine ≤ 1.5 mg/dL.
- Using a moderate dose of atorvastatin (40 mg or equivalent dose of other statins).
- Moderate to high-risk for CIN.
Key exclusion criteria (12 listed)
- Patients suffering from ST-segment elevation myocardial infarction (STEMI)
- Patients need for immediate cardiac catheterization
- Elevated liver enzymes (Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) three times the upper limit of normal).
- Active infection.
- Any contraindication to carvedilol, or atorvastatin.
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 | Drug | Group (A) |
| Carvedilol | Drug | Group (B) |
| salineAlso: 0.9%NaCl | Drug | Group (A), Group (B), Group (C) |
Primary outcome
development of contrast induced nephropathy
Time frame: 1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure.
CIN :(defined as absolute rise in the baseline serum creatinine concentration by 0.5 mg/dL after 48 hours from CC).
1 secondary outcome
Estimated Glomerular filtration rate (eGFR)
Time frame: on admission, and re-calculated 48 hours post CC using
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 Mar 2019.
- Individual participant dataSharing planned: Yes. All medical history included medication and disease, in addition to our study outcomes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin, Carvedilol and saline in people with Contrast-induced Nephropathy, run by rabab ahmed mohamed.
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 4 inclusion and 12 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 Mar 2019. 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 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?
development of contrast induced nephropathy (time frame: 1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure.). 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 Mar 2019.