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

NCT01098149 | Completed DMC

• 1 other identifier: THIRD-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 5

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.

Conditions

Hypotension; Hemodialysis

Keywords

Haemodialysis treatment tolerance; acetate free biofiltration; frequency of hypotensive events during dialysis; nurse intervention during dialysis

Outcome Measures

Primary Outcomes (1)

• 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: * systolic blood pressure less then 90 mmHg; * systolic blood pressure more then 25 mmHg to the predialysis value, with hypotensive events requiring therapies; * systolic blood pressure less then 90 mmHg with hypotensive events requiring therapies for those patients, which predialysis systolic blood pressure value was 100 mmHg.

  3 months

Secondary Outcomes (1)

• 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.

  3 months

Study Arms (2)

AFB stand alone

ACTIVE COMPARATOR

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

Other: BD and BVC, AFB

BD and BVC

ACTIVE COMPARATOR

Patients are switched into bicarbonate dialysis with Blood Volume Control

Other: BD and BVC, AFB

Interventions

BD and BVC, AFB OTHER

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

Also known as: Biofeedback,Blood Volume Control,Acetate Free Biofiltration

AFB stand alone; BD and BVC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (5)

Hospital "Santa Maria della Scaletta"

Imola, Bologna, Italy

Location

Hospital "Nuovo Ronco"

Gussago, Brescia, Italy

Location

Hospital "Policlinico S.Orsola-Malpighi"

Bologna, Italy

Location

Hospital "Spedali Civili"

Brescia, Italy

Location

Hospital "Degli Infermi"

Rimini, Italy

Location

Related Publications (4)

• 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.

  PMID: 8678065 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.

  PMID: 9568857 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.

  PMID: 12164888 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.

  PMID: 10916105 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Giovanni Cancarini, MD

  Università of Brescia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: April 2, 2010
• Study Start: March 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 2, 2010

Record last verified: 2010-03

Locations

IT (5)