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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) (NICIR)

D

David Garcia Cinca

Status and phase

Completed
Phase 3

Conditions

Renal Insufficiency

Treatments

Drug: Bicarbonate endovenous hydratation
Drug: Saline endovenous hydratation
Other: Oral hydratation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade III under study conducting contrasted computed tomography.

Enrollment

264 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients of both sexes over 18 years
  • Candidates for a study with computed tomography and intravenous contrast
  • A glomerular filtration rate between 30 and 45 mL / min including both determinations
  • 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

Exclusion criteria

  • refuse to participate in the study
  • pregnancy or lactation
  • Other risk factors for Contrast Induced Nephropathy: diabetes mellitus type I, have an age of 75 years or above, heart failure (defined by a scale New York Heart Association 3 or 4), hypotension (defined as systolic blood pressure <100), being treated with nephrotoxic medications.
  • 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

264 participants in 2 patient groups

Oral hydratation
Experimental group
Treatment:
Other: Oral hydratation
Endovenous hydratation
Active Comparator group
Treatment:
Drug: Bicarbonate endovenous hydratation
Drug: Saline endovenous hydratation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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