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.
Investigators
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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