Clinical trial NCT01098149: Tolerance to Hemodialysis in Insulin-Requiring Diabetic Patients: BD vs AFB With Blood Volume Biofeedback
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Hemodialysis
Keywords: Haemodialysis treatment tolerance
acetate free biofiltration
frequency of hypotensive events during dialysis
nurse intervention during dialysis
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2010-04-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* End stage renal disease patients
* Patients affected by diabetic nephropathy with insulin therapy, for, at least, 6 months
* Patients with renal replacement therapy with haemodialysis three time a week, for, at least, 6 months.
* Age between 18 and 85 years

Exclusion Criteria:

* Patients affected by neoplasm and/or mental illness
* Patients with residual diuresis \> 500 ml/die;
* Patients in single needle bicarbonate dialysis.

Primary outcomes:
measure: Investigate a possible better tolerance to dialysis, eliminating acetate in the dialysate bath, with AFB treatment, and using, at the same time, the automatic blood volume control (BVC).
timeFrame: 3 months
Secondary outcomes:
measure: The secondary outcome measure is to evaluate the relative efficiency of each factor (AFB in the bath and blood volume control) to reach this result.
timeFrame: 3 months
Other outcomes:
Locations:
city: Imola
country: Italy
facility: Hospital "Santa Maria della Scaletta"
state: Bologna
city: Gussago
country: Italy
facility: Hospital "Nuovo Ronco"
state: Brescia
city: Bologna
country: Italy
facility: Hospital "Policlinico S.Orsola-Malpighi"
city: Brescia
country: Italy
facility: Hospital "Spedali Civili"
city: Rimini
country: Italy
facility: Hospital "Degli Infermi"
Study officials:
affiliation: Università of Brescia
name: Giovanni Cancarini, MD
role: STUDY_CHAIR
References:
citation: Movilli E, Camerini C, Zein H, D'Avolio G, Sandrini M, Strada A, Maiorca R. A prospective comparison of bicarbonate dialysis, hemodiafiltration, and acetate-free biofiltration in the elderly. Am J Kidney Dis. 1996 Apr;27(4):541-7. doi: 10.1016/s0272-6386(96)90165-1.
citation: Verzetti G, Navino C, Bolzani R, Galli G, Panzetta G. Acetate-free biofiltration versus bicarbonate haemodialysis in the treatment of patients with diabetic nephropathy: a cross-over multicentric study. Nephrol Dial Transplant. 1998 Apr;13(4):955-61. doi: 10.1093/ndt/13.4.955.
citation: Santoro A, Mancini E, Basile C, Amoroso L, Di Giulio S, Usberti M, Colasanti G, Verzetti G, Rocco A, Imbasciati E, Panzetta G, Bolzani R, Grandi F, Polacchini M. Blood volume controlled hemodialysis in hypotension-prone patients: a randomized, multicenter controlled trial. Kidney Int. 2002 Sep;62(3):1034-45. doi: 10.1046/j.1523-1755.2002.00511.x.
citation: Ronco C, Brendolan A, Milan M, Rodeghiero MP, Zanella M, La Greca G. Impact of biofeedback-induced cardiovascular stability on hemodialysis tolerance and efficiency. Kidney Int. 2000 Aug;58(2):800-8. doi: 10.1046/j.1523-1755.2000.00229.x.