Randomized Controlled Trial of Individualized Dialysate Cooling for Cardiac Protection in Hemodialysis Patients

Clin J Am Soc Nephrol. 2015 Aug 7;10(8):1408-17. doi: 10.2215/CJN.00200115. Epub 2015 May 11.

Abstract

Background and objectives: Cardiovascular disease is the most common cause of death in patients on hemodialysis (HD). HD-associated cardiomyopathy is appreciated to be driven by exposure to recurrent and cumulative ischemic insults resulting from hemodynamic instability of conventionally performed intermittent HD treatment itself. Cooled dialysate reduces HD-induced recurrent ischemic injury, but whether this confers long-term protection of the heart in terms of cardiac structure and function is not known.

Design, setting, participants, & measurements: Between September 2009 and January 2013, 73 incident HD patients were randomly assigned to a dialysate temperature of 37°C (control) or individualized cooling at 0.5°C below body temperature (intervention) for 12 months. Cardiac structure, function, and aortic distensibility were assessed by cardiac magnetic resonance imaging. Mean between-group difference in delivered dialysate temperature was 1.2°C±0.3°C. Treatment effects were determined by the interaction of treatment group with time in linear mixed models.

Results: There was no between-group difference in the primary outcome of left ventricular ejection fraction (1.5%; 95% confidence interval, -4.3% to 7.3%). However, left ventricular function assessed by peak systolic strain was preserved by the intervention (-3.3%; 95% confidence interval, -6.5% to -0.2%) as was diastolic function (measured as peak diastolic strain rate, 0.18 s(-1); 95% confidence interval, 0.02 to 0.34 s(-1)). Reduction of left ventricular dilation was demonstrated by significant reduction in left ventricular end-diastolic volume (-23.8 ml; 95% confidence interval, -44.7 to -2.9 ml). The intervention was associated with reduced left ventricular mass (-15.6 g; 95% confidence interval, -29.4 to -1.9 g). Aortic distensibility was preserved in the intervention group (1.8 mmHg(-1)×10(-3); 95% confidence interval, 0.1 to 3.6 mmHg(-1)×10(-3)). There were no intervention-related withdrawals or adverse events.

Conclusions: In patients new to HD, individualized cooled dialysate did not alter the primary outcome but was well tolerated and slowed the progression of HD-associated cardiomyopathy. Because cooler dialysate is universally applicable at no cost, the intervention warrants wider adoption or confirmation of these findings in a larger trial.

Keywords: clinical trial; heart disease; hemodialysis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Aorta / physiopathology
  • Cardiomyopathies / diagnosis
  • Cardiomyopathies / etiology
  • Cardiomyopathies / physiopathology
  • Cardiomyopathies / prevention & control*
  • Cold Temperature*
  • England
  • Female
  • Hemodialysis Solutions / adverse effects
  • Hemodialysis Solutions / therapeutic use*
  • Humans
  • Linear Models
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Myocardial Contraction
  • Prospective Studies
  • Renal Dialysis / adverse effects
  • Renal Dialysis / methods*
  • Risk Factors
  • Stroke Volume
  • Time Factors
  • Treatment Outcome
  • Vascular Stiffness
  • Ventricular Function, Left

Substances

  • Hemodialysis Solutions