Phase 2 N=271 Randomized Prevention

Sodium Chloride and Contrast Nephropathy

Kidney Failure, Chronic · Kidney Failure, Acute · Heart Failure · Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT03476460 ↗

Enrolled (actual)

271

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration — 5; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Oral sodium chloride (Drug); Intravenous sodium chloride (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Hospital Universitario Ramon y Cajal
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration	5; 4	—
SECONDARY Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline	66.4; 68.8	0.299
SECONDARY Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline	66.1; 67.9	0.477
SECONDARY Serum Creatinine at 24h From Baseline	1.10; 1.02	0.042 sig
SECONDARY Serum Creatinine at 48h From Baseline	1.10; 1.04	0.121
SECONDARY Cystatin C at 24h From Baseline	1.38; 1.33	0.418
SECONDARY Cystatin C at 48h From Baseline	1.36; 1.36	0.901
SECONDARY Albumin-to-creatinine Ratio at 24h From Baseline	17.2; 17.0	0.720
SECONDARY Albumin-to-creatinine Ratio at 48h From Baseline	17.6; 18.2	0.688
SECONDARY Urea at 24h From Baseline	43.7; 42.2	0.535
SECONDARY Urea at 48h From Baseline	46.0; 43.5	0.338
SECONDARY Serum Sodium at 24h From Baseline	139.4; 139.3	0.764
SECONDARY Serum Sodium at 48h From Baseline	139.2; 139.4	0.458
SECONDARY Serum Potassium at 24h From Baseline	4.4; 4.4	0.893
SECONDARY Serum Potassium at 48h From Baseline	4.4; 4.5	0.645

Summary

This phase II, open, non-inferiority, randomized and controlled clinical trial is aimed to ascertain the incidence of contrast nephropathy in outpatients undergoing CT scan with contrast. Patients will be randomized to receive oral prophylaxis with capsules of sodium chloride and free water ingestion or prophylaxis with sodium chloride 0.9% intravenous solution. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol. Patients >65 years, of both sexes, with at least one of the following criteria: diabetes, stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min), undergoing CT scan with contrast, and who give written informed consent, will be included in the study. Patients with estimated glomerular filtration rate 0.3 mg/dL from baseline, or the reduction of estimated glomerular filtration rate (MDRD-4) >25% from baseline, in the first 48 hours after contrast administration.

Eligibility Criteria

Inclusion Criteria

Patients >65 years,
Both sexes,
With at least one of the following criteria: diabetes or stable heart failure or chronic kidney disease (estimated glomerular filtration rate between 30 and 60 ml/min),
Undergoing CT scan with contrast
Written informed consent.

Exclusion Criteria

Estimated glomerular filtration rate <30 ml/min,
Serum potassium <3.5 mEq/L,
Infusion of iodine contrast in the previous 15 days,
Administration of nephrotoxic drugs in the previous 72 hours or expected in the following hours after contrast infusion,
Decompensated chronic conditions (heart failure, chronic obstructive pulmonary disease, hypertension),
Allergy to iodine contrast,
Presence of hyperchloremia or hypernatremia.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03476460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.