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

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ClinicalTrials.gov Identifier: NCT02799368
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : October 10, 2017
Sponsor:
Collaborators:
Kyungpook National University
National Medical Center, Seoul
National Health Insurance Service Ilsan Hospital
Seoul National University Bundang Hospital
Bundang CHA Hospital
Seoul St. Mary's Hospital
Seoul National University Boramae Hospital
Severance Hospital
Ewha Womans University Mokdong Hospital
Incheon St.Mary's Hospital
Gachon University Gil Medical Center
Information provided by (Responsible Party):
Kwon wook Joo, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury Renal Insufficiency, Chronic Contrast Media Reaction Drug: CJ Plasma Solution A Injection Drug: CJ 0.9% Normal Saline Injection Phase 3

Detailed Description:

Iodinated contrast media (CM) has been widely used for various diagnostic and therapeutic interventions. Coronary angiography and contrast enhanced computed tomography are representative medical procedure in which CM administration is necessary, and their usage are recently extended. Also, U.S sales of medical imaging CM has been increased.

Although iodinated CM has useful role in many medical procedures, CM is well known for its renal side effect, contrast induced acute kidney injury (CI-AKI). CI-AKI is one of the leading cause of iatrogenic acute kidney injury (AKI). Moreover, CI-AKI is known to be an independent risk factor for short- and long term morbidity and mortality. Considering the current rising incidence of CI-AKI, its prevention has been an important issue.

The incidence of CI-AKI is below 5% and up to 25% according to presence of risk factors such as renal failure, diabetes mellitus, heart failure, old age and concomitant use of nephrotoxic medications. Chronic kidney disease (CKD) is an established risk factor for CI-AKI and therefore several guidelines recommend prophylaxis for CI-AKI when patients with creatinine clearance (CrCl) below 60mL/min receives CM administration. In those guidelines, it is generally recommend that high risk patients should receive isotonic crystalloid solution and be considered for taking N-acetylcysteine, although there are still debates on its benefit.

Several clinical studies have compared 0.9% saline and sodium bicarbonate solution for their effectiveness on CI-AKI prevention, and no superiority was shown in using sodium bicarbonate solution. Hence, most organization currently use 0.9% saline for CI-AKI prophylaxis due to its wide availability.

However, several studies showed that 0.9% saline has supra-physiologic dose of chloride and induces metabolic acidosis which contributes renal vasoconstriction and impairment of estimated glomerular filtration rate (eGFR). Double blind, randomized clinical human study proved that these problems are less pronounced with the use of balanced salt solution, which has physiologic level of chloride and neutral pH. Also, recent prospective pilot study suggested that using chloride restrictive solutions, rather than using chloride rich solutions, for fluid resuscitation in critically ill patients can reduce AKI. Considering the above findings, few large scale cohort studies and randomized controlled trials are ongoing to prove preventive effect of balanced salt solution for AKI over 0.9% saline.

In conclusion, as stated above, use of 0.9% saline for CI-AKI prophylaxis might have limited benefit only by volume expansion. Considering its components, additional physiologic advantage by using balanced salt solution could be achieved. In order to assess this hypothesis, the investigators planned a multicenter prospective randomized controlled open-label trial comparing balanced salt solution and 0.9% saline to prevent CI-AKI.

The primary end-point of this study is event of CI-AKI, which is defined by relative (≥25%) or fixed (≥0.5mg/dL) increase in serum creatinine from baseline value assessed at 48 hours after CM use. The secondary end-point are decrease in eGFR of more than 50% from the baseline eGFR within 48 hours and initiation of dialysis and mortality, after 1 or 6 month from CM exposure. For this purpose, at least 830 subjects would be required for each group when type I error rate is 2.5% and type II error is 20%, given 20% drop-out rate during the study period.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized, Open Label, Active Control, 2 Parallel Groups, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Balanced Salt Solution Versus 0.9% Saline in Patients With High Risk of Contrast Induced Nephropathy.
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: CJ Plasma Solution A Injection
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
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.

Active Comparator: CJ 0.9% Normal Saline Injection
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
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.




Primary Outcome Measures :
  1. Contrast Induced Acute Kidney Injury [ Time Frame: 0-48 hour ]
    Relative (≥25%) or fixed (≥0.5mg/dL) increase in serum creatinine


Secondary Outcome Measures :
  1. Decrease in renal function [ Time Frame: 0-48 hour ]
    Decrease in eGFR of more than 50% from the baseline eGFR

  2. 1 month Renal replacement therapy [ Time Frame: 0 to 30 days ]
    Initiation of renal replacement therapy

  3. 6 month Renal replacement therapy [ Time Frame: 0 to 180 days ]
    Initiation of renal replacement therapy

  4. 1 month Mortality [ Time Frame: 0 to 30 days ]
    Mortality

  5. 6 month Mortality [ Time Frame: 0 to 180 days ]
    Mortality

  6. Acute Kidney Injury by KDIGO guideline after CT scan [ Time Frame: 0-48 hour ]
    Relative (≥50%) or fixed (≥0.3mg/dL) increase in serum creatinine (otherwise specified in the latest release of KDIGO guideline)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799368


Contacts
Contact: Kwon-Wook Joo, MD, PhD 82-2-2072-1964 junephro@gmail.com
Contact: Dong Ki Kim, MD, PhD 82-2-2072-2303 dkkim73@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-752
Contact: Kwon Wook Joo, Prof    82-2-2072-1964    junephro@gmail.com   
Principal Investigator: Kwon Wook Joo, Prof         
Sponsors and Collaborators
Seoul National University Hospital
Kyungpook National University
National Medical Center, Seoul
National Health Insurance Service Ilsan Hospital
Seoul National University Bundang Hospital
Bundang CHA Hospital
Seoul St. Mary's Hospital
Seoul National University Boramae Hospital
Severance Hospital
Ewha Womans University Mokdong Hospital
Incheon St.Mary's Hospital
Gachon University Gil Medical Center
Investigators
Study Chair: Kwon-Wook Joo, MD, PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kwon wook Joo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02799368     History of Changes
Other Study ID Numbers: BS-CCT-01
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions