Chronic Kidney DiseaseNCT02829450
Peritoneal Ultrafiltration to Treat Congestive Heart Failure
An observational study of Chronic Kidney Disease and Congestive Heart Failure, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether the treatment of peritoneal ultrafiltration can improve survival and quality of life of refractory congestive heart failure with special accent on preserving residual renal function and peritoneal membrane characteristics/ Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Congestive Heart Failure
- What is being tested?
- peritoneal ultrafiltration
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Oct 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with chronic kidney disease and congestive heart failure refractory to medical therapy will be referred to peritoneal dialysis center by treating nephrologist or cardiologist. After identification and approval of candidate by dialysis nurse, the incident patients who meet the inclusion criteria, will be referred for peritoneal catheter insertion.
Who may be able to join
- diagnosis of heart failure NYHA 3-4 on maximal treatment with evidence of diuretic resistance and repeated hospital admissions due to fluid overload (at least 2 in previous 3 months)
- evidence of CKD stage 3-4
- agreement to place dialysis catheter in the peritoneal cavity for PD treatment or IV access for hemodialysis
- available medical records 1 year before dialysis treatment
Who cannot join
- unstable hemodynamic or respiratory condition
- need for vasopressor support
- patient refusal
- lack of family support or housing conditions needed for PD treatment
- evidence of active kidney disease (obstructive uropathy, glomerulonephritis, vasculitis etc.) at recruitment to the study
- contraindications for peritoneal ultrafiltration treatment (active intraabdominal or abdominal wall inflammatory process, morbid obesity, multiple abdominal surgery in the past)
- non compliance with treatment protocol
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
SorokaUMC
Beersheba, 84000
Marina Vorobiov, MD PhD, 97286400373, marinavo@clalit.org.il
Anna Basok, MD, 97286404056, annaba@calilt.org.il
About this study
Official title: Home-based Ultrafiltration for Congestive Heart Failure: Impact on Survival, Hospitalizations Rate, Quality of Life, Peritoneal Membrane Characteristics and Residual Renal Function With Different Treatment Modes
The purpose of this study is to determine whether the treatment of peritoneal ultrafiltration can improve survival and quality of life of refractory congestive heart failure with special accent on preserving residual renal function and peritoneal membrane characteristics/
Read the detailed description
Congestive heart failure (CHF) is the leading cause of acute hospital admissions. The morbidity associated with this condition presents a major health and economic challenge, which is anticipated to increase in the aging of population especially in developed countries.
Peritoneal dialysis (PD) in patients with diuretic resistant cardio-renal syndrome type 2 enables low-molecular weight solute clearance and ultrafiltration (UF) without serious hemodynamic changes, which makes this modality attractive for chronic CHF treatment . The key practical advantage of PD is that the patient can be treated at home, with treatment adjustment in accordance with his current condition. The additional advantages are: continuous UF, flexible schedule, no need for devices or anticoagulation, no need for medical staff.
Despite the fact that there was no significant improvement of survival in CHF patients treated by PD, as compared to regular treatment, improvement of symptoms, physical performance, quality of life , biochemical profile, and significant decrease in hospitalization rate have been reported.
PD has a number of both theoretical and practical advantages for extending treatment in CHF patients, but there is little experience in this field and limited knowledge regarding its influence on peritoneal membrane and renal function in patients with moderate renal failure.
Aims of the study:
- primary aim - to find out if there is survival benefit on PD treatment, reduced hospitalization rate and improved QOL, to compare the functional outcomes of CHF patients 1 year before dialysis treatment and on PD treatment with different types of PD fluids
- secondary aim - to choose the optimal type of dialysis treatment in term of effective UF, preservation of peritoneal membrane and residual renal function.
Research question: Whether UF improves survival and QOL in patients with severe CHF. What are the modes of PD and HD treatment ensuring the least possible negative impact on peritoneal membrane and residual renal function? Research hypothesis: UF improves survival and QOL in patients with severe CHF. Low glucose dialysis solutions are preferable treatment for CHF patient on PD for preservation of residual renal function and peritoneal membrane characteristics.
Possible risks preventing: early peritoneal membrane failure and deterioration of renal function, symptoms of fluid overload and need for inpatient treatment.
Type of study: observational prospective Population: CHF patients referred to nephrologist for home-based UF (PD) or medical or hemodialysis treatment
Inclusion criteria:
- diagnosis of heart failure NYHA 3-4 on maximal treatment with evidence of diuretic resistance and repeated hospital admissions due to fluid overload (at least 2 in previous 3 months)
- evidence of CKD stage 3-4
- agreement to place dialysis catheter in the peritoneal cavity for PD treatment or IV access for hemodialysis
- available medical records 1 year before dialysis treatment
Exclusion criteria:
- unstable hemodynamic or respiratory condition
- need for vasopressor support
- patient refusal
- lack of family support or housing conditions needed for PD treatment
- evidence of active kidney disease (obstructive uropathy, glomerulonephritis, vasculitis etc.) at recruitment to the study Accrual rate: 10 -20 patients per year, 40-80 patient overall Enrolment mode: The patients will be referred to peritoneal dialysis center by treating nephrologist or cardiologist. After identification and approval of candidate by dialysis nurse, the incident patients who meet the inclusion criteria, will be referred for peritoneal catheter insertion.
Intervention: PD catheter insertion by nephrologist or surgeon and PD treatment by dialysis fluids in according to clinical needs of the patient. Monitoring of clinical symptoms of fluid overload, hospital admissions, UF rate, peritoneal membrane damage parameters (cell-free DNA in peritoneal effluent, peritoneal equilibration test) and residual renal function markers (eGFR creatinine based , KT/V, urinary markers , PET) at the start of the treatment, each 3 months during the treatment and at each change of prescription. Complications of all kinds will be recorded.
Comparison group: CHF patients referred to nephrologist for home-based UF (PD) treatment and who preferred to continue conventional treatment.
- Conditions
- Chronic Kidney Disease, Congestive Heart Failure
- Being tested
- peritoneal ultrafiltration
- Keywords
- peritoneal ultrafiltration, congestive heart failure, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peritoneal ultrafiltrationOther
Peritoneal fluids should be inserted intraperitoneally for several hours dwell
| Study group | Role | What they receive |
|---|---|---|
| PD | Patients with CHF and chronic renal disease which started the treatment with peritoneal ultrafiltration.
The patients will be follow up every 3 months for assesment of symptoms, QOL questionary, routine blood and urine tests and also for assesment of residual renal function and peritoneal membrane function: monitoring of clinical symptoms of fluid overload, hospital admissions, UF rate, peritoneal membrane damage parameters (cell-free DNA in peritoneal effluent, peritoneal equilibration test) and residual renal function markers (eGFR creatinine or cystatin C based , KT/V, urinary markers) at the start of the treatment, each 3 months during the treatment and at each change of prescription. Complications of all kinds will be recorded. Receives: Other: peritoneal ultrafiltration | |
| Control | Patients with CHF and chronic renal disease which preferred to continue their regular treatment or choose other then peritoneal ultrafiltration type of renal replacement therapy (data from medical records): clinical symptoms of fluid overload, hospital admissions, urine volume,residual renal function markers (eGFR creatinine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 1 year
Secondary outcomes (5)
ultrafiltration changes required change in peritoneal fluid prescription
Measured: 1 year
decrease in urine volume
Measured: 1 year
hospitalization for uncompensated heart failure
Measured: 1 year
complications, necessitating peritoneal catheter or hemodialysis catheter
Measured: 1 year
deterioration of renal function (every increasing in CKD stage)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina Vorobiov, MD PhD, Principal investigator, Soroka UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829450
- Sponsor's protocol ID
- SOR-110-15-CTIL
- Status last verified
- Jun 2016
- First submitted
- 7 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Meguid El Nahas A, Bello AK. Chronic kidney disease: the global challenge. Lancet. 2005 Jan 22-28;365(9456):331-40. doi: 10.1016/S0140-6736(05)17789-7.
PubMed 15664230Davies S, Lally F, Satchithananda D, Kadam U, Roffe C. Extending the role of peritoneal dialysis: can we win hearts and minds? Nephrol Dial Transplant. 2014 Sep;29(9):1648-54. doi: 10.1093/ndt/gfu001. Epub 2014 Feb 10.
PubMed 24520118Cnossen TT, Kooman JP, Krepel HP, Konings CJ, Uszko-Lencer NH, Leunissen KM, van der Sande FM. Prospective study on clinical effects of renal replacement therapy in treatment-resistant congestive heart failure. Nephrol Dial Transplant. 2012 Jul;27(7):2794-9. doi: 10.1093/ndt/gfr756. Epub 2012 Apr 6.
PubMed 22492829Hall MJ, Levant S, DeFrances CJ. Hospitalization for congestive heart failure: United States, 2000-2010. NCHS Data Brief. 2012 Oct;(108):1-8.
PubMed 23102190Wankowicz Z, Prochnicka A, Olszowska A, Baczynski D, Krzesinski P, Dziuk M. Extracorporeal versus peritoneal ultrafiltration in diuretic-resistant congestive heart failure--a review. Med Sci Monit. 2011 Dec;17(12):RA271-81. doi: 10.12659/msm.882118.
PubMed 22129914Prochnicka A, Krzesinski P, Halas K, Dziuk M, Niemczyk S, Wankowicz Z. Diuretic-resistant congestive heart failure treated successfully with peritoneal ultrafiltration. Kardiol Pol. 2013;71(4):393-5. doi: 10.5603/KP.2013.0067.
PubMed 23788345Ishimoto Y, Mise N, Tanaka M, Sugahara M, Kanemitsu T, Kobayashi M, Uchida L, Kotera N, Tanaka S, Sugimoto T. Peritoneal dialysis combined with extracorporeal ultrafiltration in refractory heart failure: a case report. Perit Dial Int. 2013 Sep-Oct;33(5):582-3. doi: 10.3747/pdi.2012.00212. No abstract available.
PubMed 24133088Ramachandran K, Speer CG, Fiddy S, Reis IM, Singal R. Free circulating DNA as a biomarker of prostate cancer: comparison of quantitation methods. Anticancer Res. 2013 Oct;33(10):4521-9.
PubMed 24123025
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Ultrafiltration for Congestive Heart Failure: Impact on Survival, Hospitalizations Rate, Quality of Life, Peritoneal Membrane Characteristics and Residual Renal Function With Different Treatment Modes
- ClinicalTrials.gov ID
- NCT02829450
- Acronym / sponsor ID
- SOR-110-15-CTIL
- Conditions
- Chronic Kidney Disease, Congestive Heart Failure
- Keywords
- peritoneal ultrafiltration, congestive heart failure, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 12 Jul 2016 (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.
The purpose of this study is to determine whether the treatment of peritoneal ultrafiltration can improve survival and quality of life of refractory congestive heart failure with special accent on preserving residual renal function and peritoneal membrane characteristics/
Detailed description
Congestive heart failure (CHF) is the leading cause of acute hospital admissions. The morbidity associated with this condition presents a major health and economic challenge, which is anticipated to increase in the aging of population especially in developed countries.
Peritoneal dialysis (PD) in patients with diuretic resistant cardio-renal syndrome type 2 enables low-molecular weight solute clearance and ultrafiltration (UF) without serious hemodynamic changes, which makes this modality attractive for chronic CHF treatment . The key practical advantage of PD is that the patient can be treated at home, with treatment adjustment in accordance with his current condition. The additional advantages are: continuous UF, flexible schedule, no need for devices or anticoagulation, no need for medical staff.
Despite the fact that there was no significant improvement of survival in CHF patients treated by PD, as compared to regular treatment, improvement of symptoms, physical performance, quality of life , biochemical profile, and significant decrease in hospitalization rate have been reported.
PD has a number of both theoretical and practical advantages for extending treatment in CHF patients, but there is little experience in this field and limited knowledge regarding its influence on peritoneal membrane and renal function in patients with moderate renal failure.
Aims of the study:
- primary aim - to find out if there is survival benefit on PD treatment, reduced hospitalization rate and improved QOL, to compare the functional outcomes of CHF patients 1 year before dialysis treatment and on PD treatment with different types of PD fluids
- secondary aim - to choose the optimal type of dialysis treatment in term of effective UF, preservation of peritoneal membrane and residual renal function.
Research question: Whether UF improves survival and QOL in patients with severe CHF. What are the modes of PD and HD treatment ensuring the least possible negative impact on peritoneal membrane and residual renal function? Research hypothesis: UF improves survival and QOL in patients with severe CHF. Low glucose dialysis solutions are preferable treatment for CHF patient on PD for preservation of residual renal function and peritoneal membrane characteristics.
Possible risks preventing: early peritoneal membrane failure and deterioration of renal function, symptoms of fluid overload and need for inpatient treatment.
Type of study: observational prospective Population: CHF patients referred to nephrologist for home-based UF (PD) or medical or hemodialysis treatment
Inclusion criteria:
- diagnosis of heart failure NYHA 3-4 on maximal treatment with evidence of diuretic resistance and repeated hospital admissions due to fluid overload (at least 2 in previous 3 months)
- evidence of CKD stage 3-4
- agreement to place dialysis catheter in the peritoneal cavity for PD treatment or IV access for hemodialysis
- available medical records 1 year before dialysis treatment
Exclusion criteria:
- unstable hemodynamic or respiratory condition
- need for vasopressor support
- patient refusal
- lack of family support or housing conditions needed for PD treatment
- evidence of active kidney disease (obstructive uropathy, glomerulonephritis, vasculitis etc.) at recruitment to the study Accrual rate: 10 -20 patients per year, 40-80 patient overall Enrolment mode: The patients will be referred to peritoneal dialysis center by treating nephrologist or cardiologist. After identification and approval of candidate by dialysis nurse, the incident patients who meet the inclusion criteria, will be referred for peritoneal catheter insertion.
Intervention: PD catheter insertion by nephrologist or surgeon and PD treatment by dialysis fluids in according to clinical needs of the patient. Monitoring of clinical symptoms of fluid overload, hospital admissions, UF rate, peritoneal membrane damage parameters (cell-free DNA in peritoneal effluent, peritoneal equilibration test) and residual renal function markers (eGFR creatinine based , KT/V, urinary markers , PET) at the start of the treatment, each 3 months during the treatment and at each change of prescription. Complications of all kinds will be recorded.
Comparison group: CHF patients referred to nephrologist for home-based UF (PD) treatment and who preferred to continue conventional treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD | – | Other: peritoneal ultrafiltrationPatients with CHF and chronic renal disease which started the treatment with peritoneal ultrafiltration. The patients will be follow up every 3 months for assesment of symptoms, QOL questionary, routine blood and urine tests and also for assesment of residual renal function and peritoneal membrane function: monitoring of clinical symptoms of fluid overload, hospital admissions, UF rate, peritoneal membrane damage parameters (cell-free DNA in peritoneal effluent, peritoneal equilibration test) and residual renal function markers (eGFR creatinine or cystatin C based , KT/V, urinary markers) at the start of the treatment, each 3 months during the treatment and at each change of prescription. Complications of all kinds will be recorded. |
| Control | – | –Patients with CHF and chronic renal disease which preferred to continue their regular treatment or choose other then peritoneal ultrafiltration type of renal replacement therapy (data from medical records): clinical symptoms of fluid overload, hospital admissions, urine volume,residual renal function markers (eGFR creatinine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with chronic kidney disease and congestive heart failure refractory to medical therapy will be referred to peritoneal dialysis center by treating nephrologist or cardiologist. After identification and approval of candidate by dialysis nurse, the incident patients who meet the inclusion criteria, will be referred for peritoneal catheter insertion.
Key inclusion criteria (4 listed)
- diagnosis of heart failure NYHA 3-4 on maximal treatment with evidence of diuretic resistance and repeated hospital admissions due to fluid overload (at least 2 in previous 3 months)
- evidence of CKD stage 3-4
- agreement to place dialysis catheter in the peritoneal cavity for PD treatment or IV access for hemodialysis
- available medical records 1 year before dialysis treatment
Key exclusion criteria (7 listed)
- unstable hemodynamic or respiratory condition
- need for vasopressor support
- patient refusal
- lack of family support or housing conditions needed for PD treatment
- evidence of active kidney disease (obstructive uropathy, glomerulonephritis, vasculitis etc.) at recruitment to the study
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 |
|---|---|---|
| peritoneal ultrafiltrationPeritoneal fluids should be inserted intraperitoneally for several hours dwell | Other | PD |
Primary outcome
all cause mortality
Time frame: 1 year
5 secondary outcomes
ultrafiltration changes required change in peritoneal fluid prescription
Time frame: 1 year
decrease in urine volume
Time frame: 1 year
hospitalization for uncompensated heart failure
Time frame: 1 year
complications, necessitating peritoneal catheter or hemodialysis catheter
Time frame: 1 year
deterioration of renal function (every increasing in CKD stage)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Background: PubMed 15664230Meguid El Nahas A, Bello AK. Chronic kidney disease: the global challenge. Lancet. 2005 Jan 22-28;365(9456):331-40. doi: 10.1016/S0140-6736(05)17789-7.
- Background: PubMed 24520118Davies S, Lally F, Satchithananda D, Kadam U, Roffe C. Extending the role of peritoneal dialysis: can we win hearts and minds? Nephrol Dial Transplant. 2014 Sep;29(9):1648-54. doi: 10.1093/ndt/gfu001. Epub 2014 Feb 10.
- Background: PubMed 22492829Cnossen TT, Kooman JP, Krepel HP, Konings CJ, Uszko-Lencer NH, Leunissen KM, van der Sande FM. Prospective study on clinical effects of renal replacement therapy in treatment-resistant congestive heart failure. Nephrol Dial Transplant. 2012 Jul;27(7):2794-9. doi: 10.1093/ndt/gfr756. Epub 2012 Apr 6.
- Background: PubMed 23102190Hall MJ, Levant S, DeFrances CJ. Hospitalization for congestive heart failure: United States, 2000-2010. NCHS Data Brief. 2012 Oct;(108):1-8.
- Background: PubMed 22129914Wankowicz Z, Prochnicka A, Olszowska A, Baczynski D, Krzesinski P, Dziuk M. Extracorporeal versus peritoneal ultrafiltration in diuretic-resistant congestive heart failure--a review. Med Sci Monit. 2011 Dec;17(12):RA271-81. doi: 10.12659/msm.882118.
- Background: PubMed 23788345Prochnicka A, Krzesinski P, Halas K, Dziuk M, Niemczyk S, Wankowicz Z. Diuretic-resistant congestive heart failure treated successfully with peritoneal ultrafiltration. Kardiol Pol. 2013;71(4):393-5. doi: 10.5603/KP.2013.0067.
- Background: PubMed 24133088Ishimoto Y, Mise N, Tanaka M, Sugahara M, Kanemitsu T, Kobayashi M, Uchida L, Kotera N, Tanaka S, Sugimoto T. Peritoneal dialysis combined with extracorporeal ultrafiltration in refractory heart failure: a case report. Perit Dial Int. 2013 Sep-Oct;33(5):582-3. doi: 10.3747/pdi.2012.00212. No abstract available.
- Background: PubMed 24123025Ramachandran K, Speer CG, Fiddy S, Reis IM, Singal R. Free circulating DNA as a biomarker of prostate cancer: comparison of quantitation methods. Anticancer Res. 2013 Oct;33(10):4521-9.
- Individual participant dataSharing planned: No
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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.
Marina Vorobiov, MD PhD principal investigator
Soroka UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Congestive Heart Failure, run by Soroka University Medical Center at 1 site in Israel.
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 7 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: status not confirmed, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Vorobiov, MD PhD (97286400373, marinavo@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 1 year). 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 NCT02829450, which also lists 8 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 12 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.