HypotensionTHIRDNCT01098149
Tolerance to Hemodialysis in Insulin-Requiring Diabetic Patients: BD vs AFB With Blood Volume Biofeedback
A study testing BD and BVC, AFB in people with Hypotension and Hemodialysis, run by Università degli Studi di Brescia at 5 sites in Italy.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypotension, Hemodialysis
- What is being tested?
- BD and BVC, AFB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 5 sitesItaly
- Study dates
- Mar 2006to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients affected by neoplasm and/or mental illness
- Patients with residual diuresis > 500 ml/die;
- Patients in single needle bicarbonate dialysis.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Hospital "Policlinico S.Orsola-Malpighi"
Bologna
Hospital "Spedali Civili"
Brescia
Hospital "Nuovo Ronco"
Gussago, Brescia
Hospital "Santa Maria della Scaletta"
Imola, Bologna
Hospital "Degli Infermi"
Rimini
About this study
Official 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)
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.
Read the 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
- Being tested
- BD and BVC, AFB
- Keywords
- Haemodialysis treatment tolerance, acetate free biofiltration, frequency of hypotensive events during dialysis, nurse intervention during dialysis
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD and BVC, AFBOther
Also called Biofeedback,Blood Volume Control,Acetate Free Biofiltration
Some patients are randomized into the AFB, the others into the BD and BVC
| Study group | Role | What they receive |
|---|---|---|
| AFB stand alone | Active comparator | Patients are switched in AFB treatment, without blood volume control. Receives: Other: BD and BVC, AFB |
| BD and BVC | Active comparator | Patients are switched into bicarbonate dialysis with Blood Volume Control Receives: Other: BD and BVC, AFB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMar 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Cancarini, MD, Study chair, Università of Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098149
- Sponsor's protocol ID
- THIRD-01
- Acronym
- THIRD
- Status last verified
- Mar 2010
- First submitted
- 29 Mar 2010
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8678065Verzetti 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.
PubMed 9568857Santoro 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.
PubMed 12164888Ronco 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.
PubMed 10916105
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01098149
- Acronym / sponsor ID
- THIRD / THIRD-01
- Conditions
- Hypotension, Hemodialysis
- Keywords
- Haemodialysis treatment tolerance, acetate free biofiltration, frequency of hypotensive events during dialysis, nurse intervention during dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFB stand alone | Active comparator | Other: BD and BVC, AFBPatients are switched in AFB treatment, without blood volume control. |
| BD and BVC | Active comparator | Other: BD and BVC, AFBPatients are switched into bicarbonate dialysis with Blood Volume Control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients affected by neoplasm and/or mental illness
- Patients with residual diuresis > 500 ml/die;
- Patients in single needle bicarbonate dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD and BVC, AFBAlso: Biofeedback,Blood Volume Control,Acetate Free BiofiltrationSome patients are randomized into the AFB, the others into the BD and BVC | Other | AFB stand alone, BD and BVC |
Primary outcome
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).
Time frame: 3 months
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.
1 secondary outcome
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.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
- Background: PubMed 8678065Movilli 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.
- Background: PubMed 9568857Verzetti 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.
- Background: PubMed 12164888Santoro 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.
- Background: PubMed 10916105Ronco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Cancarini, MD study chair
Università of Brescia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD and BVC, AFB in people with Hypotension and Hemodialysis, run by Università degli Studi di Brescia at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01098149, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2010.