Sodium Chloride and Contrast Nephropathy

• Status: Completed
• Trial end date: 2019-11-29
• Target enrollment: 0
• Participant gender: All

Summary

This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast.

Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution.

The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol.

Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate <30 ml/min, serum potassium <3.5 mEq/L, infusion of iodine contrast in the previous 15 days, administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion, decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension), allergy to iodine contrast, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.

Contrast nephropathy will be defined as the increase of serum creatinine >0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Ramon y Cajal

Criteria

Inclusion Criteria:

• Patients >65 years,

• Both sexes,

• With at least one of the following criteria: diabetes or stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min),

• Undergoing CT scan with contrast

• Written informed consent.

Exclusion Criteria:

• Estimated glomerular filtration rate <30 ml/min,

• Serum potassium <3.5 mEq/L,

• Infusion of iodine contrast in the previous 15 days,

• Administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion,

• Decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension),

• Allergy to iodine contrast,

• Presence of hyperchloremia or hypernatremia.