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Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

B

Barretos Cancer Hospital

Status and phase

Completed
Phase 2

Conditions

Radiographic Contrast Agent Nephropathy

Treatments

Drug: NaCl
Drug: sodium bicarbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT00540904
1-Silva

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 2 patient groups

sodium bicarbonate
Active Comparator group
Description:
Solution 154 mEq/L of sodium bicarbonate
Treatment:
Drug: sodium bicarbonate
Sodium chloride
Active Comparator group
Description:
Solution of 154 mEq/L of NaCl
Treatment:
Drug: NaCl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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