Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
This study has been completed.
Sponsor:
Hospital de Cancer de Barretos - Fundacao Pio XII
Information provided by:
Hospital de Cancer de Barretos - Fundacao Pio XII
ClinicalTrials.gov Identifier:
NCT00540904
First received: October 5, 2007
Last updated: October 2, 2009
Last verified: October 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Contrast Induced Nephropathy |
Drug: sodium bicarbonate Drug: NaCl |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Sodium bicarbonate
U.S. FDA Resources
Further study details as provided by Hospital de Cancer de Barretos - Fundacao Pio XII:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Solution 154 mEq/L of sodium bicarbonate
|
Drug: sodium bicarbonate
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.
|
|
Active Comparator: 2
Solution of 154 mEq/L of NaCl
|
Drug: NaCl
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- > 18 years old
- cancer diagnosis
- GFR < 60 and > 30 ml/min/1,73m2 by MDRD formula or diabetic
- CT with contrast
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540904
Locations
| Brazil | |
| Hospital do Cancer de Barretos - Fundação PIO XII | |
| Barretos, São Paulo, Brazil, 14784-400 | |
Sponsors and Collaborators
Hospital de Cancer de Barretos - Fundacao Pio XII
Investigators
| Principal Investigator: | Ricardo G Silva, MD | Hospital do Cancer de Barretos - Fundação PIO XII |
More Information
Publications:
| Responsible Party: | Ricardo Gonçalves da Silva, Fundação PIO XII de Barretos |
| ClinicalTrials.gov Identifier: | NCT00540904 History of Changes |
| Other Study ID Numbers: | 1-Silva |
| Study First Received: | October 5, 2007 |
| Last Updated: | October 2, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Hospital de Cancer de Barretos - Fundacao Pio XII:
|
contrast nephropathy bicarbonate prevention |
Additional relevant MeSH terms:
|
Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013