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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: David Garcia Cinca · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
OTHER	Oral hydratation	500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography
DRUG	Bicarbonate endovenous hydratation	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.
DRUG	Saline endovenous hydratation	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.

Timeline

• Start date: 2017-07-04
• Primary completion: 2019-07-15
• Completion: 2019-07-15
• First posted: 2016-08-19
• Last updated: 2021-02-02

Locations

1 site across 1 country: Spain