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Clinical Trials/EUCTR2013-001229-15-ES
EUCTR2013-001229-15-ES
Active, not recruiting
Phase 1

The efficacy of oral and intravenous administration of sodium chloride in the prophylaxis of nephropathy induced by iodinated contrasts in outpatients

Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal0 sites266 target enrollmentJune 26, 2013
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ConditionsPatients at high risk of developing an iodinated contrast-induced nephropathy.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsSodium chloride solution 0.9% Baxter

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients at high risk of developing an iodinated contrast-induced nephropathy.
Sponsor
Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
Enrollment
266
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 26, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal

Eligibility Criteria

Inclusion Criteria

  • •Patients will undergo performing contrast CT, as indicated by clinical practice, and after being informated, agree to participate and sign the written consent to participate in the study , and meet the following criteria:
  • •Age over 65 years
  • •One of the following risk factors for NIC: diabetes mellitus, stable heart failure or kidney failure (estimated glomerular filtration rate calculated by the MDRD\-4 between 30 and 60 ml / min)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 266

Exclusion Criteria

  • •Glomerular filtration rate below 30 ml / min.
  • •Presence of hypokalemia (serum potassium less than 3\.5 mEq / L).
  • •Other procedures with intravenous contrast in the 15 previous days.
  • •Administration of nephrotoxic drugs (NSAIDs, aminoglycosides and / or potentially nephrotoxic chemotherapy) in the previous72 hours, or after the treatment.

Outcomes

Primary Outcomes

Not specified

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