Tolerance to Hemodialysis in Insulin-Requiring Diabetic Patients: BD vs AFB With Blood Volume Biofeedback
Condition: Hypotension; Hemodialysis
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Diabetic nephropathy is becoming the most common primary renal disease in end stage renal
      disease patients. The prevalence of diabetic patients in dialysis reaches even the 30% of the
      dialysis population (USRDS) with an incidence rate, in some countries, up to 40%. The 5 years
      surviving time of diabetic patients in dialysis is about the 20% and, compared to the
      hypertension and glomerulonephritis complications, still remains the worst. Diabetes is often
      associated to several comorbid factors such as hypertension, autonomic neuropathy,
      vasculopathy, metabolic disorders (ketoacidosis, poor glycaemic control), and electrolyte
      disorders. So, the diabetic patient is fragile, with a rather poor tolerance to dialysis,
      lack of achievement of dry body weight and inadequate dialysis. In order to gain a more
      detailed insight into a possible better tolerance to dialysis, arising from the elimination
      of acetate in dialysate bath (Acetate Free Biofiltration) and from the use of an automatic
      system to control the blood volume (Blood Volume Control),the investigators would like to
      investigate the cardiovascular stability and the frequency of intradialytic symptoms in a
      prospective, randomized, cross-over study.
    

Detailed description: 
      Acetate-Free-Biofiltration (AFB) was proved to be a technique suitable to treat critical
      patients, such as elders and diabetics, because of frequency reduction of hypotensive
      episodes and symptoms during the treatment and a better control to metabolic aspects (such as
      metabolic acidosis).

      The Blood Volume Control (BVC) is a tool, that allows to improve the cardiovascular tolerance
      to the treatment, especially in hypotension-prone patients, appearing promising in the
      correction of the arterial hypertension induced by the hydro-saline overload.

      The use of BVC in AFB has been tested to verify the behaviour of the kinetics of electrolyte
      (in particular of bicarbonate) and it has got good results, in terms of a further improvement
      in treatment tolerance, for critical patients However, this therapy (AFB+BVC) was not yet
      evaluated as the dialysis tolerance improvement in diabetics concern, nor the relative
      contribution given by each factor in achieving this result.

      The study, 9 months long, is aimed to verify the treatment tolerance of insulin requiring
      diabetic patients, by using standard bicarbonate dialysis (BD), or Acetate Free Biofiltration
      (AFB) and/or a Blood Volume Control(BVC). The study is divided in three phases: the first
      one, three months long, is the baseline in standard bicarbonate dialysis, then all the
      patients are shifted to AFB with BVC, for other three months, while the last three months
      long phase, after a randomization, has the aim to identify the relative contribution of each
      factor (absence of acetate in the bath or BVC) in the treatment tolerance improvement(if
      any). The treatment tolerance will be evaluated considering the frequency of intradialytic
      hypotensive events.
    

Intervention name(s): BD and BVC, AFB
Intervention type(s): Other
Intervention description(s): Some patients are randomized into the AFB, the others into the BD and BVC
Other intervention name(s): Biofeedback,Blood Volume Control,Acetate Free Biofiltration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Haemodialysis treatment tolerance; acetate free biofiltration; frequency of hypotensive events during dialysis; nurse intervention during dialysis