Sodium Chloride and Contrast Nephropathy

Phase 2

Completed

Conditions: Diabetes
Kidney Failure, Acute
Kidney Failure, Chronic
Heart Failure

Interventions: Drug: Intravenous sodium chloride
Drug: Oral sodium chloride

Registration Number: NCT03476460

Lead Sponsor: Hospital Universitario Ramon y Cajal

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 271

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous sodium chloride	Intravenous sodium chloride	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.
Oral sodium chloride	Oral sodium chloride	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Kidney Injury During the First 48 Hours After Contrast Administration	Within 48h 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

Secondary Outcome Measures

Name	Time	Method
Albumin-to-creatinine Ratio at 24h From Baseline	24 hours from contrast administration (baseline)	Albumin-to-creatinine ratio at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Albumin-to-creatinine Ratio at 48h From Baseline	48 hours from contrast administration (baseline)	Albumin-to-creatinine ratio at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Urea at 24h From Baseline	24 hours from contrast administration (baseline)	Urea at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Urea at 48h From Baseline	48 hours from contrast administration (baseline)	Urea at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Serum Sodium at 24h From Baseline	24 hours from contrast administration (baseline)	Serum sodium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Serum Sodium at 48h From Baseline	48 hours from contrast administration (baseline)	Serum sodium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Serum Potassium at 24h From Baseline	24 hours from contrast administration (baseline)	Serum potassium at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Serum Potassium at 48h From Baseline	48 hours from contrast administration (baseline)	Serum potassium at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline	24 hours from contrast administration (baseline)	Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline	48 hours from contrast administration (baseline)	Estimated glomerular filtration rate (eGFR) according to MDRD-4 at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Serum Creatinine at 24h From Baseline	24 hours from contrast administration (baseline)	Serum creatinine at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Serum Creatinine at 48h From Baseline	48 hours from contrast administration (baseline)	Serum creatinine at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Cystatin C at 24h From Baseline	24 hours from contrast administration (baseline)	Cystatin C at 24 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.
Cystatin C at 48h From Baseline	48 hours from contrast administration (baseline)	Cystatin C at 48 hours from contrast administration (baseline), as an secondary efficacy laboratory assessment.