Contrast Induced NephropathyPhase 2NCT00634491
Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy
A Phase 2 study testing sodium bicarbonate, Acetazolamide and normal salin in people with Contrast Induced Nephropathy, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is whether Acetazolamide is effective in prevention of contrast nephropathy Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Contrast Induced Nephropathy
- What is being tested?
- sodium bicarbonate, Acetazolamide and normal salin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIran
- Study dates
- Sep 2007to Feb 2008
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient that underwent coronary angiography
Who cannot join
- serum Cr. more than 3 mg/dl
- electrolyte and acid-base imbalance
- pulmonary edema
- allergy to Acetazolamide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Acetazolamide in Prevention of Contrast Nephropathy
The purpose of this study is whether Acetazolamide is effective in prevention of contrast nephropathy
Read the detailed description
Contrast induced nephropathy is one of common causes of acute renal failure many preventive protocol existed . 240 patient that underwent coronary angiography randomly divided in three groups.Group 1,2,3 will receive Bicarbonate ,Acetazolamide+Normal salin and Normal salin respectively.We compare prevalence of contrast nephropathy in each group.
- Conditions
- Contrast Induced Nephropathy
- Being tested
- sodium bicarbonate, Acetazolamide, normal salin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonateDrug
Also called no other name
150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography
AcetazolamideDrug
Also called Diamox
Acetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography
normal salinDrug
Also called no other name
1 cc/kg/hr 6 hour before and after angiography
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 150 meq/l NaHco3 3cc/kg/hr one Hour before and 1cc/kg/hr 6 hour after angiography Receives: Drug: sodium bicarbonate |
| 2 | Active comparator | Acetazolamide 250 mg + 1cc/kg/hr normal salin 6 hour before and after angiography Receives: Drug: Acetazolamide |
| 3 | Active comparator | normal salin 1cc/kg/hr before and after angiography Receives: Drug: normal salin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased base line creatinine at least 25%
Measured: 24 hr later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Fars Heart Foundation
- Investigators
- Maryam Pakfetrat, MD, Study chair, Shiraz nephro-urology research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634491
- Sponsor's protocol ID
- 2438
- Status last verified
- Mar 2008
- First submitted
- 14 Feb 2008
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Assadi F. Acetazolamide for prevention of contrast-induced nephropathy: a new use for an old drug. Pediatr Cardiol. 2006 Mar-Apr;27(2):238-42. doi: 10.1007/s00246-005-1132-z.
PubMed 16391986
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetazolamide in Prevention of Contrast Nephropathy
- ClinicalTrials.gov ID
- NCT00634491
- Acronym / sponsor ID
- 2438
- Conditions
- Contrast Induced Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Fars Heart Foundation
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Mar 2008 (estimated)
- 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.
The purpose of this study is whether Acetazolamide is effective in prevention of contrast nephropathy
Detailed description
Contrast induced nephropathy is one of common causes of acute renal failure many preventive protocol existed . 240 patient that underwent coronary angiography randomly divided in three groups.Group 1,2,3 will receive Bicarbonate ,Acetazolamide+Normal salin and Normal salin respectively.We compare prevalence of contrast nephropathy in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: sodium bicarbonate150 meq/l NaHco3 3cc/kg/hr one Hour before and 1cc/kg/hr 6 hour after angiography |
| 2 | Active comparator | Drug: AcetazolamideAcetazolamide 250 mg + 1cc/kg/hr normal salin 6 hour before and after angiography |
| 3 | Active comparator | Drug: normal salinnormal salin 1cc/kg/hr before and after angiography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient that underwent coronary angiography
Key exclusion criteria (4 listed)
- serum Cr. more than 3 mg/dl
- electrolyte and acid-base imbalance
- pulmonary edema
- allergy to Acetazolamide
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 |
|---|---|---|
| sodium bicarbonateAlso: no other name150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography | Drug | 1 |
| AcetazolamideAlso: DiamoxAcetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography | Drug | 2 |
| normal salinAlso: no other name1 cc/kg/hr 6 hour before and after angiography | Drug | 3 |
Primary outcome
Increased base line creatinine at least 25%
Time frame: 24 hr later
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 13 Mar 2008.
- Results publication: PubMed 16391986Assadi F. Acetazolamide for prevention of contrast-induced nephropathy: a new use for an old drug. Pediatr Cardiol. 2006 Mar-Apr;27(2):238-42. doi: 10.1007/s00246-005-1132-z.
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Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
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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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Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
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.
Maryam Pakfetrat, MD study chair
Shiraz nephro-urology research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium bicarbonate, Acetazolamide and normal salin in people with Contrast Induced Nephropathy, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 4 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 13 Mar 2008. 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 Iran. 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 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?
Increased base line creatinine at least 25% (time frame: 24 hr later). 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 NCT00634491, 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 13 Mar 2008.