Clinical trial · Interventional
Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiographic Contrast Agent Nephropathy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NaCl | Drug | — | UNRESOLVED |
| sodium bicarbonate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- sodium bicarbonate
- description
- Solution 154 mEq/L of sodium bicarbonate
- interventionNames
- Drug: sodium bicarbonate
- type
- ACTIVE_COMPARATOR
- label
- Sodium chloride
- description
- Solution of 154 mEq/L of NaCl
- interventionNames
- Drug: NaCl
Primary outcomes (1)
- 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
- timeFrame
- 2 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMerten 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. PMID 15150204