Clinical trial NCT03476460: Sodium Chloride and Contrast Nephropathy
Official title: Efficacy of Oral Sodium Chloride vs iv Sodium Chloride in the Prevention of Contrast Nephropathy in Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Failure, Chronic
Kidney Failure, Acute
Heart Failure
Diabetes
Keywords: Acute kidney failure
CT scan
Iodine contrast
Sodium chloride
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Ministerio de Sanidad, Servicios Sociales e Igualdad
First posted: 2018-03-26
Enrollment: 271
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 \<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, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.

Contrast nephropathy will be defined as the increase of serum creatinine \>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.

Detailed description: 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.

In those patients randomly allocated to oral prophylaxis (n=133), patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, patients will take 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast. In those patients randomly allocated to receive sodium chloride 0.9% intravenous solution (n=133), patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection. The total dose (mmol) of sodium chloride will be the same regardless administration via. The contrast will be iodixanol (320 mg of iodine/ml, in 100 ml, at an infusion rate of 2-5 ml/sec).

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 \<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, or the presence of hyperchloremia or hypernatremia, will be excluded from the study.

Contrast nephropathy will be defined as the increase of serum creatinine \>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.

Primary outcomes:
measure: Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration
timeFrame: Within 48h after contrast administration
Secondary outcomes:
measure: Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline
timeFrame: 24 hours from contrast administration (baseline)
measure: Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline
timeFrame: 48 hours from contrast administration (baseline)
measure: Serum Creatinine at 24h From Baseline
timeFrame: 24 hours from contrast administration (baseline)
measure: Serum Creatinine at 48h From Baseline
timeFrame: 48 hours from contrast administration (baseline)
measure: Cystatin C at 24h From Baseline
timeFrame: 24 hours from contrast administration (baseline)
measure: Cystatin C at 48h From Baseline
timeFrame: 48 hours from contrast administration (baseline)
measure: Albumin-to-creatinine Ratio at 24h From Baseline
timeFrame: 24 hours from contrast administration (baseline)
measure: Albumin-to-creatinine Ratio at 48h From Baseline
timeFrame: 48 hours from contrast administration (baseline)
measure: Urea at 24h From Baseline
timeFrame: 24 hours from contrast administration (baseline)
measure: Urea at 48h From Baseline
timeFrame: 48 hours from contrast administration (baseline)
measure: Serum Sodium at 24h From Baseline
timeFrame: 24 hours from contrast administration (baseline)
measure: Serum Sodium at 48h From Baseline
timeFrame: 48 hours from contrast administration (baseline)
measure: Serum Potassium at 24h From Baseline
timeFrame: 24 hours from contrast administration (baseline)
measure: Serum Potassium at 48h From Baseline
timeFrame: 48 hours from contrast administration (baseline)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: Luis Manzano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suarez Carantona C, Escobar Cervantes C, Fabregate M, Lopez Rodriguez M, Bara Ledesma N, Soto Perez-Olivares J, Ruiz Ortega RA, Lopez Castellanos G, Olavarria Delgado A, Blazquez Sanchez J, Gomez Del Olmo V, Moralejo Martin M, Pumares Alvarez MB, Sanchez Gallego MC, Llacer P, Liano F, Manzano L. Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial. J Clin Med. 2023 Apr 19;12(8):2965. doi: 10.3390/jcm12082965.