Status:

COMPLETED

Sodium Chloride and Contrast Nephropathy

Lead Sponsor:

Hospital Universitario Ramon y Cajal

Collaborating Sponsors:

Instituto de Salud Carlos III

Ministerio de Sanidad, Servicios Sociales e Igualdad

Conditions:

Kidney Failure, Chronic

Kidney Failure, Acute

Eligibility:

All Genders

65+ years

Phase:

PHASE2

Brief 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 wi...

Detailed Description

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 wi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 29 2019

Estimated Enrollment :

271 Patients enrolled

Trial Details

Trial ID

NCT03476460

Start Date

April 1 2014

End Date

November 29 2019

Last Update

March 20 2025

Active Locations (1)

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1

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034