Balanced Salt Solution Versus 0.9% Saline Infusion for Prevention of Contrast-induced Acute Kidney Injury (BASIC Trial)

• Status: Completed
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

As iodinate contrast media (CM) has been widely used in current medical practice, contrast induced acute kidney injury (CI-AKI) has been an important issue.

Previously, many guidelines suggested prophylaxis protocol using 0.9% saline when CM is administrated to high risk patients. However, recent studies showed that 0.9% saline might induce metabolic acidosis due to its supra-physiologic chloride component, and therefore renal vasoconstriction. In spite of protective effect by volume expansion with saline infusion, this renal vasoconstriction might have conflicting effect on renal function, as hypoxic injury is suspected to be the main cause of CI-AKI.

In contrast to 0.9% saline, balanced salt solution has physiologic level of chloride and neutral pH. Also, recent studies proved preventive effect of balanced salt solution for AKI in several clinical settings.

Hence, the investigators planned a prospective randomized controlled trial comparing 0.9% saline and balanced salt solution to prevent CI-AKI.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Bundang CHA Hospital; Ewha Womans University Mokdong Hospital; Gachon University Gil Medical Center; Incheon St.Mary's Hospital; Kyungpook National University; Kyungpook National University Hospital; National Health Insurance Service Ilsan Hospital; National Medical Center, Seoul; Seoul National University Boramae Hospital; Seoul National University Bundang Hospital; Seoul St. Mary's Hospital; Severance Hospital
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Individuals aged 18 years or older

• with eGFR < 45 mL/min/1.73m2 or eGFR < 60 mL/min/1.73m2 who have at least one condition Diabetes mellitus Age > 60 year

• Able and willing to provide informed consent

Exclusion Criteria:

• eGFR < 15 mL/min/1.73m2 or end stage renal disease patients with dialysis history

• Heart failure with left ventricular ejection fraction < 45% or severe symptoms (New York Heart Association functional classification III or IV)

• Decompensated heart failure patients who use dobutamine, dopamine, milrinone, amrinone, nesiritide or patients who have acute pulmonary edema

• History of hyperkalemia (serum K > 5.5 mEq/L) or hypernatremia ( serum Na > 145 mEq/L) in screening period

• Recent exposure to radiocontrast within 7 days of the study

• History of hypersensitivity to radiocontrast

• Multiple myeloma

• Pregnant/lactation

• Expected survival < 6 months

• Enrolled in other clinical trials