Kidney FailurePhase 4NCT00356954
NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization
A Phase 4 study testing N-acetylcystein and ascorbic acid in people with Kidney Failure, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The contrast induced nephropathy (CIN) has been known to be associated with significant clinical and economic consequences. Many studies were performed to find the pathophysiology and preventive measures for CIN. But the results were somewhat frustrating. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Failure
- What is being tested?
- N-acetylcystein and ascorbic acid
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2005to Apr 2006
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable Angina pectoris patients
- Patients who required the coronary catheterization
- Creatinine clearance rates =<60 mL/min using the Cockcroft-Gault formula
- Age of 19 or over 19
Who cannot join
- Pregnancy
- Lactation
- Having received contrast media within 7 days of study entry
- Emergent coronary angiography
- Acute renal failure
- End-stage renal disease requiring dialysis
Show all 16Show fewer
- History of hypersensitivity reaction to contrast media
- Cardiogenic shock
- Pulmonary edema
- Multiple myeloma
- Mechanical ventilation
- Parenteral use of diuretics
- Recent use of N-acetylcysteine
- Recent use of Ascorbic acid
- Recent use of statin
- Use of metformin or nonsteroidal anti-inflammatory drugs within 48 hours of the procedure.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital , Cardiovascular Center
Seoul
About this study
Official title: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization: NASPI Study-A Randomized Controlled Trial
The contrast induced nephropathy (CIN) has been known to be associated with significant clinical and economic consequences. Many studies were performed to find the pathophysiology and preventive measures for CIN. But the results were somewhat frustrating. Recently, it has been reported that the N-acetylcysteine and ascorbic acid might have preventive effects for CIN by their antioxidant effects.There have been no study to compare these two antioxidant.
Read the detailed description
N-acetylcysteine and ascorbic acid may prevent the CIN in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of these two antioxidant. We studied to find which of the two antioxidants is more beneficial in prevention of CIN
- Conditions
- Kidney Failure
- Being tested
- N-acetylcystein, ascorbic acid
- Keywords
- Kidney failure, Contrast media, Antioxidant, Prevention
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteinDrug
ascorbic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean peak increase of serum creatinine concentration during day1 and day2.
Secondary outcomes (4)
Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine
from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2.
Proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L)
proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startFeb 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sang-Ho Jo, M.D., Principal investigator, Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center, Hallym University Sacred Heart HospitalBon-Kwon Koo, M.D., Ph.D., Principal investigator, Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular CenterHyo-Soo Kim, M.D.,Ph.D., Study director, Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular CenterByung-Hee Oh, M.D., Ph.D., Study chair, Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356954
- Sponsor's protocol ID
- H-0509-517-158-2
- Status last verified
- Nov 2006
- First submitted
- 26 Jul 2006
- Last updated
- 27 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization: NASPI Study-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00356954
- Acronym / sponsor ID
- H-0509-517-158-2
- Conditions
- Kidney Failure
- Keywords
- Kidney failure, Contrast media, Antioxidant, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Apr 2006
- First posted
- 27 Jul 2006 (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 contrast induced nephropathy (CIN) has been known to be associated with significant clinical and economic consequences. Many studies were performed to find the pathophysiology and preventive measures for CIN. But the results were somewhat frustrating. Recently, it has been reported that the N-acetylcysteine and ascorbic acid might have preventive effects for CIN by their antioxidant effects.There have been no study to compare these two antioxidant.
Detailed description
N-acetylcysteine and ascorbic acid may prevent the CIN in the patients with underlying renal insufficiency who is undergoing the coronary angiography. The effect may derive from the antioxidant function of these two antioxidant. We studied to find which of the two antioxidants is more beneficial in prevention of CIN
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable Angina pectoris patients
- Patients who required the coronary catheterization
- Creatinine clearance rates =<60 mL/min using the Cockcroft-Gault formula
- Age of 19 or over 19
Key exclusion criteria (16 listed)
- Pregnancy
- Lactation
- Having received contrast media within 7 days of study entry
- Emergent coronary angiography
- Acute renal failure
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 |
|---|---|---|
| N-acetylcystein | Drug | – |
| ascorbic acid | Drug | – |
Primary outcome
The mean peak increase of serum creatinine concentration during day1 and day2.
4 secondary outcomes
Incidence of contrast induced nephropathy, defined as either a relative increase in serum creatinine
from baseline of >=25% or an absolute increase of >=0.5mg/dL(44.2µmol/L) during days 1 and 2.
Proportion of patients exhibiting an increase in serum creatinine of >=0.5mg/dL(44.2µmol/L)
proportion with a >=1.0 mg/dL(88.4µmol/L) increase in serum creatinine;
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 27 Nov 2006.
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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.
Sang-Ho Jo, M.D. principal investigator
Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center, Hallym University Sacred Heart Hospital
Bon-Kwon Koo, M.D., Ph.D. principal investigator
Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
Hyo-Soo Kim, M.D.,Ph.D. study director
Seoul National University Hospital, Department of Internal Medicine/ Cardiovascular Center
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 N-acetylcystein and ascorbic acid in people with Kidney Failure, run by Seoul National University Hospital at 1 site in South Korea.
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 16 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 27 Nov 2006. 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 South Korea. 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?
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?
The mean peak increase of serum creatinine concentration during day1 and day2.. 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 27 Nov 2006.