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

2014-08-27 03:14:46 | BioPortfolio


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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment






Hospital "Santa Maria della Scaletta"




Università degli Studi di Brescia

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:46-0400

Clinical Trials [194 Associated Clinical Trials listed on BioPortfolio]

Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients

Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be used to treat hypotension but lead to lower fetal pH as well. This study is to compare the effec...

Evaluation of M40403 for the Prevention of Dose Limiting Toxicities of High Dose IL-2

The clinical use of IL-2 is currently limited by development of dose-dependent hypotension (systolic blood pressure (SBP) < 90 mm Hg). The overall outcome is constant across sites with 20...

Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery

Hypotension in patients who are taken to surgery, is a very frequent complication, when the spinal anesthetical technique is used, associating this with significant adverse effects that ca...

Granisetron in Diabetic Parturients Decrease Spinal Induced Hypotension

Diabetic Parturients are exposed to intraoperative hypotension after spinal anesthesia and we proposed that intravenous Granisterone 1 mg will attenuate the hypotension occurred with spina...

Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension

Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxyg...

PubMed Articles [172 Associated PubMed Articles listed on BioPortfolio]

Postoperative Hypotension and Surgical Site Infections After Colorectal Surgery: A Retrospective Cohort Study.

Hypotension compromises local tissue perfusion, thereby reducing tissue oxygenation. Hypotension might thus be expected to promote infection. Hypotension on surgical wards, while usually less severe t...

Efficacy Of Phenylephrine Infusion Verses Colloid Preloading In Resolving Hypotension Due To Spinal Anaesthesia During Caesarean Section.

Spinal anaesthesia causes hypotension that is countered through various methods. Phenylephrine is a vasoconstrictor and haemocoel increases the intravascular vascular volume; both have an effect in pr...

Predicting factors associated with postoperative hypotension following carotid artery stenting.

and objective: Prolonged hemodynamic instability after carotid artery stenting (CAS) has been associated with increased incidence of stroke and other major adverse events. The objective of this study ...

Intracranial hypotension with coma: microsurgical repair of a spinal ventral dural tear and drainage of subdural hematoma with intracranial pressure monitoring.

Difficulties are associated with the diagnosis and management of patients with coma due to intracranial hypotension.

The association of hypotension during non-cardiac surgery, before and after skin incision, with postoperative acute kidney injury: a retrospective cohort analysis.

Intra-operative hypotension is associated with acute postoperative kidney injury. It is unclear how much hypotension occurs before skin incision compared with after, or whether hypotension in these tw...

Medical and Biotech [MESH] Definitions

A significant drop in BLOOD PRESSURE after assuming a standing position. Orthostatic hypotension is a finding, and defined as a 20-mm Hg decrease in systolic pressure or a 10-mm Hg decrease in diastolic pressure 3 minutes after the person has risen from supine to standing. Symptoms generally include DIZZINESS, blurred vision, and SYNCOPE.

An autosomal disorder of the peripheral and autonomic nervous systems limited to individuals of Ashkenazic Jewish descent. Clinical manifestations are present at birth and include diminished lacrimation, defective thermoregulation, orthostatic hypotension (HYPOTENSION, ORTHOSTATIC), fixed pupils, excessive SWEATING, loss of pain and temperature sensation, and absent reflexes. Pathologic features include reduced numbers of small diameter peripheral nerve fibers and autonomic ganglion neurons. (From Adams et al., Principles of Neurology, 6th ed, p1348; Nat Genet 1993;4(2):160-4)

Reduction of CEREBROSPINAL FLUID pressure characterized clinically by HEADACHE which is maximal in an upright posture and occasionally by an abducens nerve palsy (see ABDUCENS NERVE DISEASES), neck stiffness, hearing loss (see DEAFNESS); NAUSEA; and other symptoms. This condition may be spontaneous or secondary to SPINAL PUNCTURE; NEUROSURGICAL PROCEDURES; DEHYDRATION; UREMIA; trauma (see also CRANIOCEREBRAL TRAUMA); and other processes. Chronic hypotension may be associated with subdural hematomas (see HEMATOMA, SUBDURAL) or hygromas. (From Semin Neurol 1996 Mar;16(1):5-10; Adams et al., Principles of Neurology, 6th ed, pp637-8)

Abnormally low intraocular pressure often related to chronic inflammation (uveitis).

An ethanolamine derivative that is an adrenergic alpha agonist. It is used as a vasoconstrictor agent in the treatment of hypotension.

More From BioPortfolio on "Tolerance to Hemodialysis in Insulin-Requiring Diabetic Patients: BD vs AFB With Blood Volume Biofeedback"

Quick Search


Relevant Topic

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Searches Linking to this Trial