Contrast Induced NephropathyPhase 4NCT00950079
Prevention of Contrast-Induced Nephropathy in Diabetic Patients With Undergoing Coronary Angiography
A Phase 4 study testing Sodium bicarbonate and saline in people with Contrast Induced Nephropathy, run by CardioVascular Research Foundation, Korea at 9 sites in South Korea.
Trial summary
The aim of this study is to determine whether sodium bicarbonate is superior to sodium chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary angiography or intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Nephropathy
- What is being tested?
- Sodium bicarbonate and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Feb 2008to Jan 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18 years, no upper limits
- diabetes treated with insulin or oral hypoglycemic agents
- serum creatinine >=1.1 and
- resting estimated glomerular filtration rate <60ml/min/1.73 square meter
Who cannot join
- serum creatinine >=8mg/dL
- resting estimated GFR <15ml/min/1.73 square meter
- end stage renal disease on hemodialysis
- multiple myeloma
- uncontrolled hypertension (systolic BP >160mmHg or diastolic BP>100mmHg)
- acute myocardial infarction
Show all 11Show fewer
- emergent coronary angioplasty or angiography
- recent use of contrast within 2 days
- allergic reaction to contrast
- pregnancy
- allergic to following medication : theophylline, dopamine, mannitol, fenoldopam, N-acetylcysteine
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites, 9 recruiting
- Recruiting
Soonchunhyang University Bucheon Hospital
Bucheon-si
Nae-Hee Lee, MD, PhD
Nae-Hee Lee, MD, PhD
- Recruiting
Busan Saint Mary Hospital
Busan
Jae-Sik Jang, MD
Jae-Sik Jang, MD
- Recruiting
Soonchunhyang University Hospital, Cheonan
Cheonan
Won-Yong Shin, MD, PhD
Dong-Gyu Jin, MD, PhD
- Recruiting
Kangwon National University Hospital
Chuncheon
Bong-Ki Lee, MD, PhD
Bong-Ki Lee
- Recruiting
Chungnam National University Hospital
Daejeon
In-Whan Seong, MD, PhD
In-Whan Seong, MD, PhD
- Recruiting
Gangneung Asan Hospital
Gangneung
Sang-Sik Cheong
Sang-Sik Cheong, MD, PhD
- Recruiting
Asan Medical Center
Seoul, 138-736
Seong-Wook Park, MD, PhD, 2-3010-3153 ext. 82, swpark@amc.seoul.kr
Seung-Whan Lee, MD, PhD, 2-3010-3170 ext. 82, seungwlee@amc.seoul.kr
- Recruiting
Soonchunhyang University Seoul Hospital
Seoul
Min-Su Hyun, MD, PhD
Min-Su Hyun, MD, PhD
- Recruiting
Ulsan University Hospital
Ulsan
Sang-Gon Lee, MD, PhD
Sang-Gon Lee, MD, PhD
About this study
Official title: Preventive Strategies of REnal Insufficiency in Patients With Diabetes Undergoing InterVENTion or Arteriography(PREVENT Trial)
The aim of this study is to determine whether sodium bicarbonate is superior to sodium chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary angiography or intervention.
Read the detailed description
Contrast induced nephropathy (CIN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity or mortality, and cost. CIN has been reported to account for 10% of hospital acquired renal failure. Several strategies or medications were tried to prevent CIN. Of these, mucomyst and normal saline infusion are effective to prevent CIN. Sodium bicarbonate has shown mixed results from recent randomized trials. Moreover,limited data have been available for preventing CIN in diabetic renal dysfunction undergoing coronary angiography or intervention. Our hypothesis is that addition of sodium bicarbonate will be more efficacious than normal saline in preventing CIN at above situation.
- Conditions
- Contrast Induced Nephropathy
- Being tested
- Sodium bicarbonate, saline
- Keywords
- sodium bicarbonate, diabetes mellitus, coronary angiography or intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure
salineDrug
0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Experimental | sodium bicarbonate Receives: Drug: Sodium bicarbonate |
| Saline | Active comparator | saline infusion Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast-induced nephropathy
Measured: 24 and 48 hours after angiography or intervention
Secondary outcomes (8)
all-cause mortality
Measured: 30 days after index angiography
stroke
Measured: 30 days after index angiography
Dialysis
Measured: 30 days after index angiography
Myocardial infarction
Measured: 30 days after index angiography
all-cause mortality
Measured: 30 days to 6 months after index angiography
stroke
Measured: 30 days to 6 months after index angiography
dialysis
Measured: 30 days to 6 months after index angiography
myocardial infarction
Measured: 30 days to 6 months after index angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startFeb 2008
- Primary completionAug 2009 (estimated)
- Study completionJan 2010 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioVascular Research Foundation, Korea
- Sponsor type
- University, hospital or other
- Investigators
- Seong-Wook Park, MD, PhD, Principal investigator, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950079
- Sponsor's protocol ID
- 2007-0180
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2009
- Last updated
- 31 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Strategies of REnal Insufficiency in Patients With Diabetes Undergoing InterVENTion or Arteriography(PREVENT Trial)
- ClinicalTrials.gov ID
- NCT00950079
- Acronym / sponsor ID
- 2007-0180
- Conditions
- Contrast Induced Nephropathy
- Keywords
- sodium bicarbonate, diabetes mellitus, coronary angiography or intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- CardioVascular Research Foundation, KoreaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 31 Jul 2009 (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 aim of this study is to determine whether sodium bicarbonate is superior to sodium chloride in preventing contrast induced nephropathy in diabetic patients undergoing coronary angiography or intervention.
Detailed description
Contrast induced nephropathy (CIN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity or mortality, and cost. CIN has been reported to account for 10% of hospital acquired renal failure. Several strategies or medications were tried to prevent CIN. Of these, mucomyst and normal saline infusion are effective to prevent CIN. Sodium bicarbonate has shown mixed results from recent randomized trials. Moreover,limited data have been available for preventing CIN in diabetic renal dysfunction undergoing coronary angiography or intervention. Our hypothesis is that addition of sodium bicarbonate will be more efficacious than normal saline in preventing CIN at above situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Drug: Sodium bicarbonatesodium bicarbonate |
| Saline | Active comparator | Drug: salinesaline infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age>18 years, no upper limits
- diabetes treated with insulin or oral hypoglycemic agents
- serum creatinine >=1.1 and
- resting estimated glomerular filtration rate <60ml/min/1.73 square meter
Key exclusion criteria (11 listed)
- serum creatinine >=8mg/dL
- resting estimated GFR <15ml/min/1.73 square meter
- end stage renal disease on hemodialysis
- multiple myeloma
- uncontrolled hypertension (systolic BP >160mmHg or diastolic BP>100mmHg)
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 bicarbonate3 mL/kg for 1 hour immediately before contrast injection , 1mg/kg/hr during procedure and 6 hours after procedure | Drug | Sodium bicarbonate |
| saline0.9% normal saline with 1 mL/kg/hr infusion 12 hours before procedure and 12 hours after procedure | Drug | Saline |
Primary outcome
Incidence of contrast-induced nephropathy
Time frame: 24 and 48 hours after angiography or intervention
8 secondary outcomes
all-cause mortality
Time frame: 30 days after index angiography
stroke
Time frame: 30 days after index angiography
Dialysis
Time frame: 30 days after index angiography
Myocardial infarction
Time frame: 30 days after index angiography
all-cause mortality
Time frame: 30 days to 6 months after index angiography
stroke
Time frame: 30 days to 6 months after index angiography
dialysis
Time frame: 30 days to 6 months after index angiography
myocardial infarction
Time frame: 30 days to 6 months after index angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2009.
Related trials for Contrast Induced Nephropathy
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
Not yet recruitingObservational study
An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
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.
Seong-Wook Park, MD, PhD principal investigator
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium bicarbonate and saline in people with Contrast Induced Nephropathy, run by CardioVascular Research Foundation, Korea at 9 sites 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 11 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 31 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seong-Wook Park, MD, PhD (2-3010-3153 ext. 82, swpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of contrast-induced nephropathy (time frame: 24 and 48 hours after angiography or intervention). 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 31 Jul 2009.