Hypotension Clinical Trial
— THIRDOfficial 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)
Verified date | March 2010 |
Source | Università degli Studi di Brescia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Hospital "Policlinico S.Orsola-Malpighi" | Bologna | |
Italy | Hospital "Spedali Civili" | Brescia | |
Italy | Hospital "Nuovo Ronco" | Gussago | Brescia |
Italy | Hospital "Santa Maria della Scaletta" | Imola | Bologna |
Italy | Hospital "Degli Infermi" | Rimini |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi di Brescia |
Italy,
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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: frequency of hypotensive events, during dialysis (defined as above); number of nurse interventions (defined as ultrafiltration rate stop, or saline infusion); antihypertensive drugs. |
3 months | No |
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