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Clinical Trials/EUCTR2016-002032-33-ES
EUCTR2016-002032-33-ES
Active, not recruiting
Phase 1

Comparative study of the efficacy of oral versus intravenous hydration as a preventive measure of contrast-induced nephropathy (CIN) in patients with renal insufficiency (RI) grade III under study conducting Computed Tomography (CT)

Fundacio Privada Clinic per a la Recerca Biomedica0 sitesJuly 15, 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with renal failure undergoing a computed tomography scan with contrast
Sponsor
Fundacio Privada Clinic per a la Recerca Biomedica
Status
Active, not recruiting
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 15, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundacio Privada Clinic per a la Recerca Biomedica

Eligibility Criteria

Inclusion Criteria

  • a) Patients of both sexes over 18 years
  • b) Candidates for a study with computed tomography and intravenous contrast
  • c) Pesenten a glomerular filtration rate between 30 and 45 mL / min including both determinations
  • d) They have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its representative legally designated for inclusion in the clinical trial
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 350
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 36

Exclusion Criteria

  • a) refuse to participate in the study
  • b) Pregnancy or lactation
  • c) Other risk factors for Contrast Induced Nephropathy:
  • \- Diabetes mellitus
  • \- Have an age of 70 years or above
  • \- Heart failure (defined by a scale New York Heart Association \- NYHA 3 or 4\)
  • \- Hypotension (defined as systolic blood pressure \<100\)
  • \- Being treated with nephrotoxic medications.
  • d) Any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.

Outcomes

Primary Outcomes

Not specified

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