Sodium Chloride and Contrast Nephropathy

NCT ID: NCT03476460

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 271 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-01
• Study Completion Date: 2019-11-29

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.

Conditions

Kidney Failure, Chronic; Kidney Failure, Acute; Heart Failure; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral sodium chloride

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Intravenous sodium chloride

Intervention Type: DRUG

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.

Interventions

Oral sodium chloride

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Ministerio de Sanidad, Servicios Sociales e Igualdad

OTHER_GOV

Sponsor Role: collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Luis Manzano Espinosa

MD, PhD, Chief of Internal Medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis Manzano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

Locations

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 37109303 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EC11-132

Identifier Type: -

Identifier Source: org_study_id