Emergent Coronary ProcedurePhase 4NCT00700375
Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection
A Phase 4 study testing Sodium bicarbonate and Sodium Chloride in people with Emergent Coronary Procedure, run by Osaka General Medical Center at 1 site in Japan.
Trial summary
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Emergent Coronary Procedure
- What is being tested?
- Sodium bicarbonate and Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2008to Mar 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing an emergent coronary procedure(within 60 minutes from admission)
Who cannot join
- On dialysis
- Pregnancy
- Past use of bicarbonate or N-Acetyl-Cystein in 48hr
- Past exposure to contrast media in 48hr
- Circulatory insufficiency with lactic acidosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.
Read the detailed description
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.
- Conditions
- Emergent Coronary Procedure
- Being tested
- Sodium bicarbonate, Sodium Chloride
- Keywords
- Patients undergoing an emergent coronary procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
Sodium ChlorideDrug
8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Experimental | Not described Receives: Drug: Sodium bicarbonate |
| Sodium chloride | Experimental | Not described Receives: Drug: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Contrast-induced Nephropathy
The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.
Measured: after procedure and 1,2-3day after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Emergent Coronary ProcedureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka General Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Takahisa Yamada, directorate, Study chair, OsakaGeneralMedicalCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700375
- Sponsor's protocol ID
- SBECP
- Status last verified
- Mar 2010
- First submitted
- 16 Jun 2008
- Last updated
- 20 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Contrast-Induced Nephropathy With Sodium Bicarbonate Bolus Injection in Patients Undergoing an Emergent Coronary Procedure
- ClinicalTrials.gov ID
- NCT00700375
- Acronym / sponsor ID
- SBECP
- Conditions
- Emergent Coronary Procedure
- Keywords
- Patients undergoing an emergent coronary procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Osaka General Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Posted 9 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.
Detailed description
This study is to investigate the effect of Sodium Bicarbonate bolus injection in patients undergoing an emergent coronary procedure for prevention of contrast-induced nephropathy.The End point is development of contrast-induced nephropathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Drug: Sodium bicarbonate |
| Sodium chloride | Experimental | Drug: Sodium Chloride |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing an emergent coronary procedure(within 60 minutes from admission)
Key exclusion criteria (5 listed)
- On dialysis
- Pregnancy
- Past use of bicarbonate or N-Acetyl-Cystein in 48hr
- Past exposure to contrast media in 48hr
- Circulatory insufficiency with lactic acidosis.
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 bicarbonate8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure | Drug | Sodium bicarbonate |
| Sodium Chloride8.4%sodium bicarbonate 0.5ml/kg bolus injection before procedure and hydration with 154mEq/l sodium bicarbonate 1ml/kg/Hr for 6 hours after the procedure | Drug | Sodium chloride |
Primary outcome
Occurrence of Contrast-induced Nephropathy
Time frame: after procedure and 1,2-3day after procedure
The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Emergent Coronary Procedure
Active, not recruiting
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High-Risk Percutaneous Coronary Intervention
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.
Takahisa Yamada, directorate study chair
OsakaGeneralMedicalCenter
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 Sodium bicarbonate and Sodium Chloride in people with Emergent Coronary Procedure, run by Osaka General Medical Center at 1 site in Japan.
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: finished, as of the sponsor's last update on 20 Jul 2010. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 9 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Occurrence of Contrast-induced Nephropathy (time frame: after procedure and 1,2-3day after procedure). 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 20 Jul 2010.