Low Dose Continuous Furosemide Effect on Cardiac Surgery Patients With Kidney Dysfunction
Condition: Chronic Kidney Disease; Cardiac Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Heart Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic kidney disease is an independent risk factor for cardiovascular disease associated
      with increased mortality rate during cardiac surgery in proportion to the kidney function.
      Chronic kidney disease is defined by decreased glomerular filtration rate (GFR) as classified
      by Kidney Disease: Improving Global Outcome (KDIGO). Deterioration of kidney function has a
      complex and multifactorial pathophysiologic derangement. In order to counter kidney injury
      associated with cardiac surgery, several pharmacologic and non-pharmacologic interventions
      have been studied to prevent perioperative deterioration of kidney function. Diuretics as
      pharmacologic measure are often used post-cardiac surgery to treat fluid overload and
      managing patient with acute kidney injury by preventing anuria. Loop diuretics (furosemide)
      may improve renal blood flow, decrease reabsorption in renal tubules, decrease oxygen demand
      and energy consumption (blocking potassium/sodium/2cloride co-transport in loop of Henle),
      and prevent hypoxic injury of renal medulla. Low dose continuous furosemide hypothetically
      has a protective effect on cardiac surgery patients with kidney dysfunction, measured
      improved glomerular filtration rate, decreased indication for therapeutic furosemide
      infusion, and decreased need of renal replacement therapy. On the other hand, administration
      of furosemide is rather harmful in severe kidney dysfunction. Therefore, the objective of
      this study is to determine the protective effect of low-dose continuous furosemide
      perioperative in cardiac surgery patients with mild to moderate kidney dysfunction.
    

Detailed description: 
      The study was a double-blind randomized controlled trial to determine the protective effect
      of low-dose continuous furosemide perioperative in cardiac surgery patients with mild to
      moderate kidney dysfunction. Ethical clearance for the study was approved by Institutional
      Review Board of National Cardiovascular Center Harapan Kita. Patients eligible for the study
      was recruited and written informed consent was obtained after clear explanation of the study.
      Allocation of furosemide and control group was done using simple computer randomization by
      staff who was not involved in the study. Furosemide infusion and normal saline was prepared
      by independent pharmacist blinded to the study. Furosemide solution was prepared to contain
      40 mg of furosemide diluted with normal saline to a total volume of 40 cc (1 mg / 1 cc) and
      control solution was prepared to contain only 40 cc of normal saline. Both solution was
      packaged in 50-cc syringe and prepared in similar fashion. The solution was administered
      after induction of anesthesia with rate of 2 cc per hour for 12 hours.

      Baseline participant were collected before surgery. All cardiac surgery procedure was done in
      concordance to hospital standard operating procedure. The primary outcomes of the study were
      glomerular filtration rate, need of diuretic infusion dose after intervention, need of renal
      replacement therapy and the secondary outcomes were ICU length of stay and in hospital
      mortality. The calculated sample size estimated was 41 participants per group, accounting for
      drop-out rate, expected sample size was 45 participants per group (90 participants in total).
    

Intervention name(s): Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL); NaCl 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): Furosemide 2 mg/hour infusion for 12 hours since induction; NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Other intervention name(s): Lasix injection
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Furosemide; Kidney Dysfunction; Glomerular Filtration Rate