Contrast Induced Kidney Injury.Phase 3BOSSNCT00930436
Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease
A Phase 3 study testing sodium bicarbonate in people with Contrast Induced Kidney Injury., run by MD Scientific at 17 sites in United States.
Trial summary
Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography procedure with contrast agent will be asked if they are willing to join the trial. If so they will be screened and randomized to receive either sodium bicarbonate or saline before, during and after the contrast media is given. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Kidney Injury.
- What is being tested?
- sodium bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 17 sitesUnited States
- Study dates
- Jan 2010to Sep 2012
- Phase
- Phase 3
- 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
- Candidate for angiography
- Stage 3B, 4 or 5 Chronic kidney disease (i.e. eGFR <=44)
- Either sex over 18 years of age
Who cannot join
- Pregnant or breast feeding
- On any kidney replacement list
- Gastric tube in place or gastric drainage
- Uncorrected hypoglycemia
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
St Luke's Heart and Vascular Center
Bethlehem, Pennsylvania, 18015
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Fletcher Allen Hospital
Burlington, Vermont, 05401
The Christ Hospital
Cincinnati, Ohio
Baylor Heart and Vascular Hospital
Dallas, Texas, 75227
Geisinger Medical Center
Danville, Pennsylvania, 17822
Hackensack University Medical Center
Hackensack, New Jersey, 07601
St Luke's Health System
Kansas City, Missouri, 64111
Osceola Regional Medical Center
Kissimmee, Florida, 34741
Centennial Medical Center
Nashville, Tennessee, 37203
Mt Sinai School of Medcine
New York, New York, 10029
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital (Lifespan)
Providence, Rhode Island, 02906
Redmond Regional Medical Center
Rome, Georgia, 30165
St. Johns Hospital
Springfield, Illinois, 62701
Northside Hospital
St. Petersburg, Florida, 33709
Stony Brook University Medical Center
Stony Brook, New York
About this study
Official title: Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography
Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography procedure with contrast agent will be asked if they are willing to join the trial. If so they will be screened and randomized to receive either sodium bicarbonate or saline before, during and after the contrast media is given. They will be asked for serum samples 1 to 3 days, 7, 30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has reduced the incidence of contrast induced chronic kidney disease by measuring their serum creatinine, as well as whether they have required renal dialysis or other renal replacement therapy.
- Conditions
- Contrast Induced Kidney Injury.
- Being tested
- sodium bicarbonate
- Keywords
- chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonateDrug
Serum creatinine will be measured on Days 3,7, 30, 90, and 180
| Study group | Role | What they receive |
|---|---|---|
| Saline infusion | Active comparator | Saline will be given as an active control agent to compare with sodium bicarbonate. Each bag of solution will be blinded, and given in the same manner. Receives: Drug: sodium bicarbonate |
| Sodium Bicarbonate | Experimental | Infusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours Receives: Drug: sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or renal replacement therapy or sustained kidney injury
Sustained kidney injury is two sequential 20% reduction of eGFR from baseline as calculated from change in sertum creatinine at least three weeks after receiving IP.
Measured: Over six months following treatment
Secondary outcomes (2)
A comparison between the treatments for length of hospital stay, post contrast.
Measured: Over six months after the treatment
A comparison between the treatments of the time to renal replacement therapy (any type) or death (whichever occurs first) over the 6-month observation period.
Measured: six months after receiving IP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Induced Kidney Injury.Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- MD Scientific
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930436
- Sponsor's protocol ID
- MDS001
- Acronym
- BOSS
- Status last verified
- Feb 2012
- First submitted
- 26 Jun 2009
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sodium Bicarbonate to Reduce Chronic Kidney Injury in Subjects With Advanced Chronic Kidney Disease (CKD) Who Are Undergoing Angiography
- ClinicalTrials.gov ID
- NCT00930436
- Acronym / sponsor ID
- BOSS / MDS001
- Conditions
- Contrast Induced Kidney Injury.
- Keywords
- chronic kidney disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 391 participants (actual)
- Lead sponsor
- MD ScientificIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (estimated)
- First posted
- 30 Jun 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.
Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography procedure with contrast agent will be asked if they are willing to join the trial. If so they will be screened and randomized to receive either sodium bicarbonate or saline before, during and after the contrast media is given. They will be asked for serum samples 1 to 3 days, 7, 30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has reduced the incidence of contrast induced chronic kidney disease by measuring their serum creatinine, as well as whether they have required renal dialysis or other renal replacement therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline infusion | Active comparator | Drug: sodium bicarbonateSaline will be given as an active control agent to compare with sodium bicarbonate. Each bag of solution will be blinded, and given in the same manner. |
| Sodium Bicarbonate | Experimental | Drug: sodium bicarbonateInfusion of sodium bicarbonate will be given prior to,during and after the contrast agent for a total of 6 to 10 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidate for angiography
- Stage 3B, 4 or 5 Chronic kidney disease (i.e. eGFR <=44)
- Either sex over 18 years of age
Key exclusion criteria (4 listed)
- Pregnant or breast feeding
- On any kidney replacement list
- Gastric tube in place or gastric drainage
- Uncorrected hypoglycemia
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 bicarbonateSerum creatinine will be measured on Days 3,7, 30, 90, and 180 | Drug | Saline infusion, Sodium Bicarbonate |
Primary outcome
Death or renal replacement therapy or sustained kidney injury
Time frame: Over six months following treatment
Sustained kidney injury is two sequential 20% reduction of eGFR from baseline as calculated from change in sertum creatinine at least three weeks after receiving IP.
2 secondary outcomes
A comparison between the treatments for length of hospital stay, post contrast.
Time frame: Over six months after the treatment
A comparison between the treatments of the time to renal replacement therapy (any type) or death (whichever occurs first) over the 6-month observation period.
Time frame: six months after receiving IP
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
Related trials for Contrast Induced Kidney Injury.
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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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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
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sodium bicarbonate in people with Contrast Induced Kidney Injury., run by MD Scientific at 17 sites in United States.
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 3 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: stopped early, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. 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?
Death or renal replacement therapy or sustained kidney injury (time frame: Over six months following treatment). 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 23 Aug 2012.