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Clinical Trial Details

Trial ID: L1233
Source ID: NCT03476460
Associated Drug: Oral Sodium Chloride
Title: Sodium Chloride and Contrast Nephropathy
Acronym: PNIC-Na
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03476460/results
Conditions: Kidney Failure, Chronic|Kidney Failure, Acute|Heart Failure|Diabetes
Interventions: DRUG: Oral sodium chloride|DRUG: Intravenous sodium chloride
Outcome Measures: Primary: Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration, Contrast-Associated Acute Kidney Injury, defined as the increase of serum creatinine \>0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) \>25%, within 48h after contrast administration, Within 48h after contrast administration | Secondary: Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline, Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 24 hours from contrast administration (baseline)|Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline, Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 48 hours from contrast administration (baseline)|Serum Creatinine at 24h From Baseline, Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 24 hours from contrast administration (baseline)|Serum Creatinine at 48h From Baseline, Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 48 hours from contrast administration (baseline)|Cystatin C at 24h From Baseline, Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 24 hours from contrast administration (baseline)|Cystatin C at 48h From Baseline, Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 48 hours from contrast administration (baseline)|Albumin-to-creatinine Ratio at 24h From Baseline, Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 24 hours from contrast administration (baseline)|Albumin-to-creatinine Ratio at 48h From Baseline, Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 48 hours from contrast administration (baseline)|Urea at 24h From Baseline, Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 24 hours from contrast administration (baseline)|Urea at 48h From Baseline, Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 48 hours from contrast administration (baseline)|Serum Sodium at 24h From Baseline, Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 24 hours from contrast administration (baseline)|Serum Sodium at 48h From Baseline, Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 48 hours from contrast administration (baseline)|Serum Potassium at 24h From Baseline, Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 24 hours from contrast administration (baseline)|Serum Potassium at 48h From Baseline, Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment., 48 hours from contrast administration (baseline)
Sponsor/Collaborators: Sponsor: Hospital Universitario Ramon y Cajal | Collaborators: Instituto de Salud Carlos III|Ministerio de Sanidad, Servicios Sociales e Igualdad
Gender: ALL
Age: OLDER_ADULT
Phases: PHASE2
Enrollment: 271
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2014-04-01
Completion Date: 2019-11-29
Results First Posted: 2025-03-20
Last Update Posted: 2025-03-20
Locations: Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
URL: https://clinicaltrials.gov/show/NCT03476460