Hypotension Clinical Trial
Official title:
Tolerance to Hemodialysis in Insulin-Requiring Diabetic Patients: a Prospective Randomized,Cross-over Multicenter Study Between Bicarbonate Dialysis (BD) and Blood Volume Controlled Acetate-Free Biofiltration (BVC-AFB)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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