The efficacy of oral administration of sodium chloride in the prophylaxis of nephropathy induced by iodinated contrasts

The efficacy of oral and intravenous administration of sodium chloride in the prophylaxis of nephropathy induced by iodinated contrasts in outpatients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001229-15-ES

Enrollment

266

Registered

2013-06-26

Start date

2013-08-14

Completion date

Unknown

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients at high risk of developing an iodinated contrast-induced nephropathy.

Interventions

Trade Name: Sodium chloride solution 0.9% Baxter Product Name: Sodium chloride solution 0.9% Baxter Product Code: 53064 Pharmaceutical Form: Solution fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients will undergo performing contrast CT, as indicated by clinical practice, and after being informated, agree to participate and sign the written consent to participate in the study , and meet the following criteria: Age over 65 years One of the following risk factors for NIC: diabetes mellitus, stable heart failure or kidney failure (estimated glomerular filtration rate calculated by the MDRD-4 between 30 and 60 ml / min) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 266

Exclusion criteria

Exclusion criteria: Glomerular filtration rate below 30 ml / min. Presence of hypokalemia (serum potassium less than 3.5 mEq / L). Other procedures with intravenous contrast in the 15 previous days. Administration of nephrotoxic drugs (NSAIDs, aminoglycosides and / or potentially nephrotoxic chemotherapy) in the previous72 hours, or after the treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the incidence of nephropathy induced by iodinated contrasts (NIC) after the administration of oral sodium chloride in relation to intravenous risk outpatients; Secondary Objective: Study and assess the clinical utility of various biomarkers of NIC damage, both for early diagnosis of renal damage prior to stratification of risk of developing it. Develop in accordance with the results obtained a recommendation applicable to outpatients at high risk for NIC. ; Primary end point(s): NIC defined by the presence in the first 48 hours after administration of contrast, any of the following criteria, in the absence of other causes warrant: Increased serum creatinine greater than 0.3 mg / dl, compared to baseline. Reduction in glomerular filtration rate estimated by the MDRD formula (simply) more than 25% of baseline. ;Timepoint(s) of evaluation of this end point: 48 hours	—

Measure

Time frame

Main Objective: Compare the incidence of nephropathy induced by iodinated contrasts (NIC) after the administration of oral sodium chloride in relation to intravenous risk outpatients; Secondary Objective: Study and assess the clinical utility of various biomarkers of NIC damage, both for early diagnosis of renal damage prior to stratification of risk of developing it. Develop in accordance with the results obtained a recommendation applicable to outpatients at high risk for NIC. ; Primary end point(s): NIC defined by the presence in the first 48 hours after administration of contrast, any of the following criteria, in the absence of other causes warrant: Increased serum creatinine greater than 0.3 mg / dl, compared to baseline. Reduction in glomerular filtration rate estimated by the MDRD formula (simply) more than 25% of baseline. ;Timepoint(s) of evaluation of this end point: 48 hours

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 48 hours; Secondary end point(s): Plasma Cystatin C, Serum ions Venous gas analysis. Serum MicroRNAs: microRNA101 * microRNA127 microRNA126 * and . Urinary concentrations: NGAL , * KIM-1, NAG , t-gelsolin GM2AP *, and creatinine Sodium, pH, microalbuminuria and protein in a urine sample.	—

Countries

Spain

Contacts

Public ContactFIBio

Fundación para la Investigación Biomédica Hospital Ramón y Cajal

ipablo.hrca@gmail.com34913368825

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026