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

NCT02799368 | Completed Phase 3

• 1 other identifier: BS-CCT-01
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Contrast Induced Acute Kidney Injury

  Relative (≥25%) or fixed (≥0.5mg/dL) increase in serum creatinine

  0-48 hour

Secondary Outcomes (6)

• Decrease in renal function

  0-48 hour

• 1 month Renal replacement therapy

  0 to 30 days

• 6 month Renal replacement therapy

  0 to 180 days

• 1 month Mortality

  0 to 30 days

• 6 month Mortality

  0 to 180 days

Study Arms (2)

CJ Plasma Solution A Injection

EXPERIMENTAL

Before contrast media administration : CJ Plasma Solution A Injection (3mL/kg for 1 hour) After contrast media administration : CJ Plasma Solution A Injection (1.5 mL/kg/h for 4 hours)

Drug: CJ Plasma Solution A Injection

CJ 0.9% Normal Saline Injection

ACTIVE COMPARATOR

Before contrast media administration : CJ 0.9% Normal Saline Injection (3mL/kg for 1 hour) After contrast media administration : CJ 0.9% Normal Saline Injection (1.5mL/kg/h for 4 hours)

Drug: CJ 0.9% Normal Saline Injection

Interventions

CJ Plasma Solution A Injection DRUG

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.

CJ Plasma Solution A Injection

CJ 0.9% Normal Saline Injection DRUG

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.

CJ 0.9% Normal Saline Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Kyungpook National University Hospital: collaborator
• National Medical Center, Seoul: collaborator
• National Health Insurance Service Ilsan Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Bundang CHA Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator
• Seoul National University Boramae Hospital: collaborator
• Severance Hospital: collaborator
• Ewha Womans University Mokdong Hospital: collaborator
• Incheon St.Mary's Hospital: collaborator
• Gachon University Gil Medical Center: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-752, South Korea

Location

Related Publications (2)

• Park S, Kim DK, Jung HY, Kim CD, Cho JH, Cha RH, Jeong JC, Kim S, Kim HJ, Ban TH, Chung BH, Lee JP, Park JT, Han SH, Yoo TH, Ryu DR, Moon SJ, Lee JE, Huh W, Kang EW, Chang TI, Joo KW. Efficacy and Safety of a Balanced Salt Solution Versus a 0.9% Saline Infusion for the Prevention of Contrast-Induced Acute Kidney Injury After Contrast-Enhanced Computed Tomography. Kidney Med. 2020 Feb 21;2(2):189-195. doi: 10.1016/j.xkme.2019.12.003. eCollection 2020 Mar-Apr.

  PMID: 32734238 DERIVED

• Jo HA, Park S, Kim CD, Jung HY, Cho JH, Cha RH, Kang EW, Chang TI, Kim S, Kim HJ, Chung BH, Lee JP, Park JT, Han SH, Yoo TH, Ryu DR, Moon SJ, Chang JH, Kim DK, Joo KW. Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial. Trials. 2017 Oct 5;18(1):461. doi: 10.1186/s13063-017-2202-2.

  PMID: 28982378 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kwon-Wook Joo, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 14, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: March 1, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)