Tolerance to Hemodialysis in Insulin-Requiring Diabetic Patients: BD vs AFB With Blood Volume Biofeedback

NCT ID: NCT01098149

Last Updated: 2010-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2010-03-31

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.

Conditions

Hypotension; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AFB stand alone

Patients are switched in AFB treatment, without blood volume control.

Group Type: ACTIVE_COMPARATOR

BD and BVC, AFB

Intervention Type: OTHER

Some patients are randomized into the AFB, the others into the BD and BVC

BD and BVC

Patients are switched into bicarbonate dialysis with Blood Volume Control

Group Type: ACTIVE_COMPARATOR

BD and BVC, AFB

Intervention Type: OTHER

Some patients are randomized into the AFB, the others into the BD and BVC

Interventions

BD and BVC, AFB

Some patients are randomized into the AFB, the others into the BD and BVC

Intervention Type: OTHER

Other Intervention Names

Biofeedback,Blood Volume Control,Acetate Free Biofiltration

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Dept of Nephrology -Brescia

Principal Investigators

Giovanni Cancarini, MD

Role: STUDY_CHAIR

Università of Brescia

Locations

Hospital "Santa Maria della Scaletta"

Imola, Bologna, Italy

Hospital "Nuovo Ronco"

Gussago, Brescia, Italy

Hospital "Policlinico S.Orsola-Malpighi"

Bologna, , Italy

Hospital "Spedali Civili"

Brescia, , Italy

Hospital "Degli Infermi"

Rimini, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 8678065 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9568857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12164888 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10916105 (View on PubMed)

Other Identifiers

THIRD-01

Identifier Type: -

Identifier Source: org_study_id