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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFB stand alone | Active Comparator | Patients are switched in AFB treatment, without blood volume control. |
|
| BD and BVC | Active Comparator | Patients are switched into bicarbonate dialysis with Blood Volume Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD and BVC, AFB | Other | Some patients are randomized into the AFB, the others into the BD and BVC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | The treatment tolerance is measured by the number of intradialytic hypotensive events, defined as:
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The evaluation will be done on:
| 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Cancarini, MD | Università of Brescia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital "Santa Maria della Scaletta" | Imola | Bologna | Italy | |||
| Hospital "Nuovo Ronco" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8678065 | Background | 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. | |
| 9568857 | Background | 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. |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| Gussago |
| Brescia |
| Italy |
| Hospital "Policlinico S.Orsola-Malpighi" | Bologna | Italy |
| Hospital "Spedali Civili" | Brescia | Italy |
| Hospital "Degli Infermi" | Rimini | Italy |
| 12164888 | Background | 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. |
| 10916105 | Background | 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. |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |