Efficacy of Oral Sodium Chloride vs iv Sodium Chloride in the Prevention of Contrast Nephropathy in Outpatients

Sodium Chloride and Contrast Nephropathy

Sponsors

Lead sponsor: Hospital Universitario Ramon y Cajal

Source 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.

Overall Status Completed
Start Date March 1, 2014
Completion Date November 29, 2019
Primary Completion Date November 29, 2019
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of contrast nephropathy during the first 48 hours after contrast administration During the first 48 hours after contrast administration
Secondary Outcome
Measure Time Frame
Determination of biomarkers of contrast nephropathy during the first 48 hours after contrast administration During the first 48 hours after contrast administration
Enrollment 269
Condition
Intervention

Intervention type: Drug

Intervention name: Oral sodium chloride

Description: Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 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.

Arm group label: Oral sodium chloride

Intervention type: Drug

Intervention name: Intravenous sodium chloride

Description: 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.

Arm group label: Intravenous sodium chloride

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.

Gender: All

Minimum age: 65 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Luis Manzano, MD, PhD Principal Investigator Hospital Universitario Ramon y Cajal
Location
facility Hospital Universitario Ramon y Cajal
Location Countries

Spain

Verification Date

March 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Hospital Universitario Ramon y Cajal

Investigator full name: Luis Manzano Espinosa

Investigator title: MD, PhD, Chief of Internal Medicine department

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Oral sodium chloride

Arm group type: Experimental

Description: 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.

Arm group label: Intravenous sodium chloride

Arm group type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov