Acute Kidney FailurePhase 3NCT00424320
Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy
A Phase 3 study testing Sodium bicarbonate in people with Acute Kidney Failure, run by Instituto Nacional de Cardiologia Ignacio Chavez at 2 sites in Mexico.
Trial summary
The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- Sodium bicarbonate
- How many people
- 100 participants
- Where
- 2 sitesMexico
- Study dates
- Oct 2006to Jan 2007
- 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
- Age over 18 years old
- Indication for coronariography and/or percutaneous coronary intervention
- Voluntary written consent for the realization of coronariography and/or percutaneous intervention and for the participation in this clinical trial
- A MEHRAN contrast-induced nephropathy score of six or more
Who cannot join
- Patients with chronic kidney failure requiring any kind of dialysis
- Patients unable to complete follow-up
- Multiple myeloma
- Exposure to contrast 48 hours prior to study
- Pregnancy
- Patients unable to give consent
- Already receiving sodium bicarbonate solutions
- Receiving contrast media other than non-ionic
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites, 2 recruiting
- Recruiting
ABC Medical Center
Mexico City, Mexico City (d.f.), 01120
Jesús Simón Domínguez, PharmD, 52+55+52308098
Jesús Simón Domínguez, PharmD
- Recruiting
Ignacio Chávez National Institute of Cardiology
Mexico City, Mexico City (d.f:), 14080
Emma M Miranda Malpica, MD, PhD, 52+55+55732911 ext. 1236, malpicae@yahoo.com.mx
Emma M Miranda Malpica, MD, PhD
About this study
Official title: Clinical Controlled Trial to Determinate the Role of Sodium Bicarbonate in the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing to Diagnostic Coronariography and/or Percutaneous Coronary Intervention
The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy
Read the detailed description
The use of contrast media is more frequent as new diagnostic and therapeutic procedures are developed. As a consequence, the occurrence of acute renal failure (ARF), also known as contrast-induced nephropathy, is more frequently seen after the realization of these procedures, representing about 10% of all in-hospital ARF. The importance of preventing this complication is related with its strong association with higher morbidity and mortality rates in patients who present it. A number of drugs and interventions have been studied for preventing contrast-induced nephropathy, including intravenous hydration with normal and hypotonic saline solutions, oral hydration, mannitol, diuretics, dopamine and its antagonists (fenoldopam), calcium antagonists, theophylline, N-acetylcysteine, natriuretic atrial peptide and hemodialysis after or during contrast media administration.
There is only one study in humans that demonstrates the utility of the sodium bicarbonate to prevent the contrast-induced nephropathy, showing a reduction in the incidence of this complication of about 13.6%. Although this result could seem convincing, its relevance has been questioned because the definition used by the authors as contrast-induced nephropathy was an increase of 25% from basal creatinine. Although when compared, the absolute differences between basal and after-procedure creatinines were not statistically significative, the sample size was small and the participants were low-risk patients to develop contrast-induced nephropathy. It is also important to note that the control group was hydrated with a dextrose 5% solution with 154 mEq of NaCl, although today's most accepted prevention therapy is intravenous hydration with normal saline solution.
Comparison: Hydration previously, during and afterwards contrast media administration with normal saline solution (0.9%), compared to hydration previous, during and afterwards contrast media administration with a solution made of normal saline and sodium bicarbonate.
- Conditions
- Acute Kidney Failure
- Being tested
- Sodium bicarbonate
- Keywords
- Acute kidney failure, Contrast-induced nephropathy, Non-ionic contrast media, Ionic contrast media, Iopamidol, Percutaneous coronary intervention, Coronariography
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-induced nephropathy
Secondary outcomes (1)
Hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startOct 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney FailureStudies 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
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Investigators
- Emma Miranda Malpica, PhD, Principal investigator, Ignacio Chávez National Institute of CardiologyMarco A Martínez Ríos, MD, FACC, Study director, Ignacio Chávez National Institute of CardiologyJorge Gaspar Hernández, MD, Study chair, Ignacio Chávez National Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424320
- Sponsor's protocol ID
- 06-001
- Status last verified
- Jan 2007
- First submitted
- 18 Jan 2007
- Last updated
- 19 Jan 2007
- Results posted
- No
Publications
Bagshaw SM, Ghali WA. Acetylcysteine for prevention of contrast-induced nephropathy after intravascular angiography: a systematic review and meta-analysis. BMC Med. 2004 Oct 22;2:38. doi: 10.1186/1741-7015-2-38.
PubMed 15500690Itoh Y, Yano T, Sendo T, Oishi R. Clinical and experimental evidence for prevention of acute renal failure induced by radiographic contrast media. J Pharmacol Sci. 2005 Apr;97(4):473-88. doi: 10.1254/jphs.crj05002x. Epub 2005 Apr 9.
PubMed 15821342Aspelin P. Nephrotoxicity and the role of contrast media. Radiat Med. 2004 Nov-Dec;22(6):377-8. No abstract available.
PubMed 15648451Mueller C, Seidensticker P, Buettner HJ, Perruchoud AP, Staub D, Christ A, Buerkle G. Incidence of contrast nephropathy in patients receiving comprehensive intravenous and oral hydration. Swiss Med Wkly. 2005 May 14;135(19-20):286-90. doi: 10.4414/smw.2005.10938.
PubMed 15986266Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. doi: 10.1503/cmaj.1040847.
PubMed 15911862Cavusoglu E, Chhabra S, Marmur JD, Kini A, Sharma SK. The prevention of contrast-induced nephropathy in patients undergoing percutaneous coronary intervention. Minerva Cardioangiol. 2004 Oct;52(5):419-32.
PubMed 15514576Rezkalla SH. Contrast nephropathy. Clin Med Res. 2003 Oct;1(4):301-4. doi: 10.3121/cmr.1.4.301.
PubMed 15931323Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.
PubMed 15150204Briguori C, Airoldi F, Morici N, Colombo A. New pharmacological protocols to prevent or reduce contrast media nephropathy. Minerva Cardioangiol. 2005 Feb;53(1):49-58.
PubMed 15788979
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Controlled Trial to Determinate the Role of Sodium Bicarbonate in the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing to Diagnostic Coronariography and/or Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00424320
- Acronym / sponsor ID
- 06-001
- Conditions
- Acute Kidney Failure
- Keywords
- Acute kidney failure, Contrast-induced nephropathy, Non-ionic contrast media, Ionic contrast media, Iopamidol, Percutaneous coronary intervention, Coronariography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Jan 2007
- First posted
- 19 Jan 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.
The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy
Detailed description
The use of contrast media is more frequent as new diagnostic and therapeutic procedures are developed. As a consequence, the occurrence of acute renal failure (ARF), also known as contrast-induced nephropathy, is more frequently seen after the realization of these procedures, representing about 10% of all in-hospital ARF. The importance of preventing this complication is related with its strong association with higher morbidity and mortality rates in patients who present it. A number of drugs and interventions have been studied for preventing contrast-induced nephropathy, including intravenous hydration with normal and hypotonic saline solutions, oral hydration, mannitol, diuretics, dopamine and its antagonists (fenoldopam), calcium antagonists, theophylline, N-acetylcysteine, natriuretic atrial peptide and hemodialysis after or during contrast media administration.
There is only one study in humans that demonstrates the utility of the sodium bicarbonate to prevent the contrast-induced nephropathy, showing a reduction in the incidence of this complication of about 13.6%. Although this result could seem convincing, its relevance has been questioned because the definition used by the authors as contrast-induced nephropathy was an increase of 25% from basal creatinine. Although when compared, the absolute differences between basal and after-procedure creatinines were not statistically significative, the sample size was small and the participants were low-risk patients to develop contrast-induced nephropathy. It is also important to note that the control group was hydrated with a dextrose 5% solution with 154 mEq of NaCl, although today's most accepted prevention therapy is intravenous hydration with normal saline solution.
Comparison: Hydration previously, during and afterwards contrast media administration with normal saline solution (0.9%), compared to hydration previous, during and afterwards contrast media administration with a solution made of normal saline and sodium bicarbonate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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 over 18 years old
- Indication for coronariography and/or percutaneous coronary intervention
- Voluntary written consent for the realization of coronariography and/or percutaneous intervention and for the participation in this clinical trial
- A MEHRAN contrast-induced nephropathy score of six or more
Key exclusion criteria (8 listed)
- Patients with chronic kidney failure requiring any kind of dialysis
- Patients unable to complete follow-up
- Multiple myeloma
- Exposure to contrast 48 hours prior to study
- Pregnancy
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 bicarbonate | Drug | – |
Primary outcome
Contrast-induced nephropathy
1 secondary outcome
Hemodialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2007.
- Background: PubMed 15500690Bagshaw SM, Ghali WA. Acetylcysteine for prevention of contrast-induced nephropathy after intravascular angiography: a systematic review and meta-analysis. BMC Med. 2004 Oct 22;2:38. doi: 10.1186/1741-7015-2-38.
- Background: PubMed 15821342Itoh Y, Yano T, Sendo T, Oishi R. Clinical and experimental evidence for prevention of acute renal failure induced by radiographic contrast media. J Pharmacol Sci. 2005 Apr;97(4):473-88. doi: 10.1254/jphs.crj05002x. Epub 2005 Apr 9.
- Background: PubMed 15648451Aspelin P. Nephrotoxicity and the role of contrast media. Radiat Med. 2004 Nov-Dec;22(6):377-8. No abstract available.
- Background: PubMed 15986266Mueller C, Seidensticker P, Buettner HJ, Perruchoud AP, Staub D, Christ A, Buerkle G. Incidence of contrast nephropathy in patients receiving comprehensive intravenous and oral hydration. Swiss Med Wkly. 2005 May 14;135(19-20):286-90. doi: 10.4414/smw.2005.10938.
- Background: PubMed 15911862Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. doi: 10.1503/cmaj.1040847.
- Background: PubMed 15514576Cavusoglu E, Chhabra S, Marmur JD, Kini A, Sharma SK. The prevention of contrast-induced nephropathy in patients undergoing percutaneous coronary intervention. Minerva Cardioangiol. 2004 Oct;52(5):419-32.
- Background: PubMed 15931323Rezkalla SH. Contrast nephropathy. Clin Med Res. 2003 Oct;1(4):301-4. doi: 10.3121/cmr.1.4.301.
- Background: PubMed 15150204Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. doi: 10.1001/jama.291.19.2328.
- Background: PubMed 15788979Briguori C, Airoldi F, Morici N, Colombo A. New pharmacological protocols to prevent or reduce contrast media nephropathy. Minerva Cardioangiol. 2005 Feb;53(1):49-58.
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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.
Emma Miranda Malpica, PhD principal investigator
Ignacio Chávez National Institute of Cardiology
Marco A Martínez Ríos, MD, FACC study director
Ignacio Chávez National Institute of Cardiology
Jorge Gaspar Hernández, MD study chair
Ignacio Chávez National Institute of Cardiology
2 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 Acute Kidney Failure, run by Instituto Nacional de Cardiologia Ignacio Chavez at 2 sites in Mexico.
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 8 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 19 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Miranda Malpica, PhD (52+55+55499120 ext. 1232, malpicae@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-induced nephropathy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00424320, which also lists 9 linked publications.
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 19 Jan 2007.