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NCT Number: NCT02872155

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)

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.

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral hydratation

Other

500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography

Bicarbonate endovenous hydratation

Drug

Intravenous hydration: sodium (1.6 molar) Bicarbonate 3 mL / kg / h starting one hour before the computed tomography and sodium bicarbonate (1/6 M) 1 mL / kg / h during the hour after computed tomography.

Saline endovenous hydratation

Drug

If there is contraindication for administration of bicarbonate the pattern of intravenous hydration is performed with saline solution: 3 ml / kg / h for 1 hour before the procedure and normal saline 1 mL / kg / hour for hour after computed tomography.

Primary outcomes

  1. Proportion of contrast induced nephropathy

    Time frame: 48-72 hours after the completion of the computed tomography

    Contrast induced nephropathy defined as a creatinine increase> 0.5 mg

    / dl comparing the initial blood test to the blood test performed after 48-72 hours to the completion of the computed tomography

Secondary outcomes

  1. Need for hemodialysis

    Time frame: 15 days

    Need for hemodialysis for one month after completion of the computed tomography, among patients who have undergone oral or intravenous hydration

  2. Reversibility of contrast induced nephropathy

    Time frame: 15 days

    Defined as no increase in creatinine> 0.5 mg / dl compared to the initial analysis performed

  3. Proportion of adverse events

    Time frame: 15 days

    Presence of adverse events, grade 3 adverse events and serious adverse events related to the investigational products during the study follow-up

Sponsors and collaborators

Lead sponsor

David Garcia Cinca

Other

Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

Registry information

Official study title

Comparative Study of the Efficacy of Oral Versus Intravenous Hydration as a Preventive Measure of Contrast-induced Nephropathy (CIN) in Patients

Acronym: NICIR

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2016
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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