Radiographic Contrast Agent NephropathyPhase 2NCT00540904
Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
A Phase 2 study testing sodium bicarbonate and NaCl in people with Radiographic Contrast Agent Nephropathy, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiographic Contrast Agent Nephropathy
- What is being tested?
- sodium bicarbonate and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2007to Sep 2009
- Phase
- Phase 2
- 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
- > 18 years old
- cancer diagnosis
- GFR < 60 and > 30 ml/min/1,73m2 by MDRD formula or diabetic
- CT with contrast
Who cannot join
- dialysis needed
- uncontrolled hypertension
- changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure
- recent exposure to radiographic contrast agents (within previous two days of the study)
- administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital do Cancer de Barretos - Fundação PIO XII
Barretos, São Paulo, 14784-400
About this study
Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, >18 years old, with a GFR <60 and >30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed.
- Conditions
- Radiographic Contrast Agent Nephropathy
- Being tested
- sodium bicarbonate, NaCl
- Keywords
- contrast, nephropathy, bicarbonate, prevention
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonateDrug
IV 154 mEq/L sodium bicarbonate. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.
NaClDrug
IV 154 mEq/L solution of NaCl 0.9%. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection.
| Study group | Role | What they receive |
|---|---|---|
| sodium bicarbonate | Active comparator | Solution 154 mEq/L of sodium bicarbonate Receives: Drug: sodium bicarbonate |
| Sodium chloride | Active comparator | Solution of 154 mEq/L of NaCl Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast or dialysis needed
Measured: 2 days
Secondary outcomes (1)
change in serum bicarbonate change in serum potassium change in serum glucose change in serum creatinine change in estimated glomerular filtration rate incidence of contrast induced nephropathy comparison of cholesterol level
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiographic Contrast Agent 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo G Silva, MD, Principal investigator, Hospital do Cancer de Barretos - Fundação PIO XII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540904
- Sponsor's protocol ID
- 1-Silva
- Status last verified
- Feb 2014
- First submitted
- 5 Oct 2007
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Merten 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 15150204
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
- ClinicalTrials.gov ID
- NCT00540904
- Acronym / sponsor ID
- 1-Silva
- Conditions
- Radiographic Contrast Agent Nephropathy
- Keywords
- contrast, nephropathy, bicarbonate, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Oct 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.
Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, >18 years old, with a GFR <60 and >30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium bicarbonate | Active comparator | Drug: sodium bicarbonateSolution 154 mEq/L of sodium bicarbonate |
| Sodium chloride | Active comparator | Drug: NaClSolution of 154 mEq/L of NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years old
- cancer diagnosis
- GFR < 60 and > 30 ml/min/1,73m2 by MDRD formula or diabetic
- CT with contrast
Key exclusion criteria (5 listed)
- dialysis needed
- uncontrolled hypertension
- changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure
- recent exposure to radiographic contrast agents (within previous two days of the study)
- administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study
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 bicarbonateIV 154 mEq/L sodium bicarbonate. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection. | Drug | sodium bicarbonate |
| NaClIV 154 mEq/L solution of NaCl 0.9%. Infusion of 3 cc/Kg/h 1 hour before the injection of contrast and 1 cc/Kg/h after the injection. | Drug | Sodium chloride |
Primary outcome
Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast or dialysis needed
Time frame: 2 days
1 secondary outcome
change in serum bicarbonate change in serum potassium change in serum glucose change in serum creatinine change in estimated glomerular filtration rate incidence of contrast induced nephropathy comparison of cholesterol level
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
- Results publication: 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.
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.
Ricardo G Silva, MD principal investigator
Hospital do Cancer de Barretos - Fundação PIO XII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium bicarbonate and NaCl in people with Radiographic Contrast Agent Nephropathy, run by Barretos Cancer Hospital at 1 site in Brazil.
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 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 3 Mar 2014. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast or dialysis needed (time frame: 2 days). 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 NCT00540904, which also lists 1 linked publication.
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 3 Mar 2014.