Contrast Induced NephropathyNCT00494637
The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
A study testing sodium bicarbonate in people with Contrast Induced Nephropathy, run by Lenox Hill Hospital.
Trial summary
Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or… 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
- How many people
- 468 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jan 2009
- 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
- serum creatinine greater then or equal to 1.5
Who cannot join
- EF<30
- Overt CHF
- Alkalemia
- Hypokalemia
- GFR<20 cc/min
About this study
Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.
- Conditions
- Contrast Induced Nephropathy
- Being tested
- sodium bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonateDrug
isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast induced nephropathy
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionJan 2009
Why it stopped: Not reaching recruitment and endpoint goals
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lenox Hill Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Investigators
- Jordan L Rosenstock, MD, Principal investigator, Lenox Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494637
- Sponsor's protocol ID
- L06.10.058
- Status last verified
- Jan 2009
- First submitted
- 29 Jun 2007
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy
- ClinicalTrials.gov ID
- NCT00494637
- Acronym / sponsor ID
- L06.10.058
- Conditions
- Contrast Induced Nephropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not reaching recruitment and endpoint goals
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Lenox Hill HospitalUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 2 Jul 2007 (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.
Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- serum creatinine greater then or equal to 1.5
Key exclusion criteria (5 listed)
- EF<30
- Overt CHF
- Alkalemia
- Hypokalemia
- GFR<20 cc/min
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 bicarbonateisotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours | Drug | – |
Primary outcome
Incidence of contrast induced nephropathy
Time frame: 48-72 hours
Results and safety
The study was stopped early (reason given: Not reaching recruitment and endpoint goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
Related trials for Contrast Induced Nephropathy
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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
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Contrast-associated Acute Kidney Injury
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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)
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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.
Jordan L Rosenstock, MD principal investigator
Lenox Hill Hospital
Questions about this trial
What is this clinical trial studying?
A study testing sodium bicarbonate in people with Contrast Induced Nephropathy, run by Lenox Hill Hospital.
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 5 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: stopped early, as of the sponsor's last update on 28 Jan 2009. 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.
Are results available for this study?
The study was stopped early (reason given: Not reaching recruitment and endpoint goals). Results are not available in the source record.
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?
Incidence of contrast induced nephropathy (time frame: 48-72 hours). 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 28 Jan 2009.