Sodium Chloride and Contrast Nephropathy

NCT03476460 | Completed Phase 2 Results

• 1 other identifier: EC11-132
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Acute kidney failure; CT scan; Iodine contrast; Sodium chloride

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Kidney Injury During the First 48 Hours 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

  Within 48h after contrast administration

Secondary Outcomes (14)

• Estimated Glomerular Filtration Rate (eGFR) at 24h From Baseline

  24 hours from contrast administration (baseline)

• Estimated Glomerular Filtration Rate (eGFR) at 48h From Baseline

  48 hours from contrast administration (baseline)

• Serum Creatinine at 24h From Baseline

  24 hours from contrast administration (baseline)

• Serum Creatinine at 48h From Baseline

  48 hours from contrast administration (baseline)

• Cystatin C at 24h From Baseline

  24 hours from contrast administration (baseline)

Study Arms (2)

Oral sodium chloride

EXPERIMENTAL

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.

Drug: Oral sodium chloride

Intravenous sodium chloride

ACTIVE COMPARATOR

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.

Drug: Intravenous sodium chloride

Interventions

Oral sodium chloride 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.

Oral sodium chloride

Intravenous sodium chloride 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.

Intravenous sodium chloride

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead
• Instituto de Salud Carlos III: collaborator
• Ministerio de Sanidad, Servicios Sociales e Igualdad: collaborator

Study Sites (1)

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Related Publications (1)

• 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.

  PMID: 37109303 RESULT

MeSH Terms

Conditions

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

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The incidence of CA-AKI was much lower than expected at the time of study design. The definition of CA-AKI considered in our study is slightly different from that proposed in the clinical guidelines for AKI. Serial measurements of serum and urinary osmolality were not available in our trial. The trial was a single-center study, which might limit its external validity.

Results Point of Contact

• Title: Coordinator of Research Support Unit, Internal Medicine Dept.
• Organization: Hospital Universitario Ramón y Cajal, IRYCIS

martin.fabregate@salud.madrid.org

0034913369082

Study Officials

• Luis Manzano, MD, PhD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Chief of Internal Medicine department

Study Record Dates

• First Submitted: March 17, 2018
• First Posted: March 26, 2018
• Study Start: April 1, 2014
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After revision and approval of the principal investigator.
• Access Criteria: Approval of the principal investigator.

Locations

ES (1)