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

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.

Conditions

• Acute Kidney Injury
• Renal Insufficiency, Chronic
• Contrast Media Reaction

Interventions

DRUG

CJ Plasma Solution A Injection

Intravenous plasma solution (Chloride 90 mmoL/L) at 3 mL/kg over 1 hour pre-contrast, followed by the same solution intravenously at 1.5 mL/kg/hr for 4 hours. Intra-vascular low-osmolal or iso-osmolal contrast will be used.

DRUG

CJ 0.9% Normal Saline Injection

Intravenous plasma solution (Chloride 154 mmoL/L) at 3 mL/kg over 1 hour pre-contrast, followed by the same solution intravenously at 1.5 mL/kg/hr for 4 hours. Intra-vascular low-osmolal or iso-osmolal contrast will be used.

Sponsors & Collaborators

• Kyungpook National University Hospital

  collaborator OTHER

• National Medical Center, Seoul

  collaborator OTHER

• National Health Insurance Service Ilsan Hospital

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Bundang CHA Hospital

  collaborator OTHER

• Seoul St. Mary's Hospital

  collaborator OTHER

• Seoul National University Boramae Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Ewha Womans University Mokdong Hospital

  collaborator OTHER

• Incheon St.Mary's Hospital

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Kwon-Wook Joo, MD, PhD · Seoul National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2019-05-31

Completion

2020-03-31

Countries

• South Korea

Study Locations