End Stage Renal DiseaseBOCOMONCT01509937
Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (MHD) Patients
A study testing body bioimpedance spectroscopy device and Device in people with End Stage Renal Disease, run by Peking University First Hospital at 1 site in China.
Trial summary
It is hypothesized that bioimpedance spectroscope guided fluid management will help patient reach euvolemic status, and increase long term survival. Background: Bioimpedance analysis (BIA) was helpful in identifying hypervolemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- body bioimpedance spectroscopy device and Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 433 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jun 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of end stage renal disease (ESRD) and need MHD
- age of 18 years or older but 80 years or less
- on MHD for at least 3 months
- dialysis frequency of at least 5 sessions per 2 weeks, not less than 4 hours per session, Kt/V at least 1.2
- urine volume less than 800mL per 24 hours the day before dialysis session,
- bioimpedance analysis not used within recent 3 months
- dry weight regarded as adequate according to the patient's responsible doctor
- the ability to understand and willingness to sign an informed consent statement.
Who cannot join
- acute infection within 1 month
- active rheumatic disease, or current on cortical steroid medication or cytotoxic medication
- uncontrolled neoplasm
- acute myocardial infarction within 1 month
- congestive heart failure (NYHA 3 - 4)
- stroke within 3 months,
Show all 12Show fewer
- metallic installation, like contraceptive device, artificial joint(s)
- amputation
- female of childbearing age who has a pregnancy plan, or is pregnant, or on breast feeding
- having a plan to reduce dialysis frequency
- having a renal transplantation plan or planning to transfer to peritoneal dialysis within 3 years
- participating or planning to participate another clinical trial, which will confound the current study
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Nephrology, Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Randomized Controlled Trial of Long Term Effect of BCM Guided Fluid Management in MHD Patients
It is hypothesized that bioimpedance spectroscope guided fluid management will help patient reach euvolemic status, and increase long term survival.
Background: Bioimpedance analysis (BIA) was helpful in identifying hypervolemia. Observational data using BIA methods showed that hypervolemic patients on maintenance hemodialysis (MHD) suffered from high mortality risk. But it is not clear if BIA guided fluid management can improve MHD patients' survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management comparing with standard care.
Read more
Design: This is a multicenter, prospective, randomized, controlled trial. Setting and Participants: More than 1300 participants from 16 clinical sites will be included in the study. The enrollment period will last 6 months, and minimum length of follow-up will not less than 36 months. MHD patients aged more than 18 years but less than 80 years who had been on MHD for at least 3 months and considered suitable candidates will be invited to participate in the study. Participants will be randomized to BIA arm or control arm using 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM-Fresenius Medical Care D GmbH) will be used for BIA measurement at baseline for both arm, and every 2 months in BCM arm.
Predictors: BCM guided fluid management and fluid management using standard care.
Outcome and measurements: The primary intent-to-treat analysis compares composite endpoint between BCM arm and control arm. The secondary intent-to-treat analysis compares left ventricular thickness, blood pressure, medication, and incidence and length of hospitalization between BCM arm and control arm. Death, acute myocardial infarction, stroke, peripheral arterial disease will be used as composite endpoint.
- Conditions
- End Stage Renal Disease
- Being tested
- body bioimpedance spectroscopy device, Device
- Keywords
- end stage renal disease, maintenance hemodialysis, dry weight, bioimpedance spectroscopy analysis, body composition monitor, Fresenius BCM, Ultrafiltration
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body bioimpedance spectroscopy deviceDevice
Name of the device is BCM from Fresenius Medical Care D GmbH
DeviceDevice
participants in control arm will not receive BCM measurement.
| Study group | Role | What they receive |
|---|---|---|
| BCM Arm | Experimental | BCM measured every 2 months Receives: Device: body bioimpedance spectroscopy device |
| Control arm | Sham comparator | patients care according to standard of care Receives: Device: Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite endpoint
Death, acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, peripheral arterial disease will be used as composite endpoint.
Measured: during 36 months
Secondary outcomes (4)
Change from baseline in Left ventricular thickness once a year
Measured: baseline, and once a year during the following 36 months
Change from baseline in Pre-dialysis blood pressure every 2 months
Measured: baseline, every 2 months during the following 36 months
Change from baseline in anti-hypertensives DDD every 2 months
Defined daily dose (DDD) will be calculated according to WHO recommendation at baseline, and every 2 months thereafter. Trend of DDD change will be compared between the two arms.
Measured: Baseline, and every 2 months during the following 36 months
Incidence of all cause and congestive heart failure related hospitalization
Incidence of all cause and congestive heart failure related hospitalization will be compared between arms.
Measured: during the 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care (Shanghai) Co., Ltd
- Responsible party
- Principal investigator, Li Zuo, Peking University First Hospital
- Investigators
- Li Zuo, MD & PhD, Study director, Institute of Nephrology, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509937
- Sponsor's protocol ID
- BOCOMO525
- Acronym
- BOCOMO
- Status last verified
- Nov 2015
- First submitted
- 3 Jan 2012
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wizemann V, Wabel P, Chamney P, Zaluska W, Moissl U, Rode C, Malecka-Masalska T, Marcelli D. The mortality risk of overhydration in haemodialysis patients. Nephrol Dial Transplant. 2009 May;24(5):1574-9. doi: 10.1093/ndt/gfn707. Epub 2009 Jan 7.
PubMed 19131355Jansen MA, Hart AA, Korevaar JC, Dekker FW, Boeschoten EW, Krediet RT; NECOSAD Study Group. Predictors of the rate of decline of residual renal function in incident dialysis patients. Kidney Int. 2002 Sep;62(3):1046-53. doi: 10.1046/j.1523-1755.2002.00505.x.
PubMed 12164889Puskar D, Pasini J, Savic I, Bedalov G, Sonicki Z. Survival of primary arteriovenous fistula in 463 patients on chronic hemodialysis. Croat Med J. 2002 Jun;43(3):306-11.
PubMed 12035137Mizumasa T, Hirakata H, Yoshimitsu T, Hirakata E, Kubo M, Kashiwagi M, Tanaka H, Kanai H, Fujimi S, Iida M. Dialysis-related hypotension as a cause of progressive frontal lobe atrophy in chronic hemodialysis patients: a 3-year prospective study. Nephron Clin Pract. 2004;97(1):c23-30. doi: 10.1159/000077592.
PubMed 15153764John AS, Tuerff SD, Kerstein MD. Nonocclusive mesenteric infarction in hemodialysis patients. J Am Coll Surg. 2000 Jan;190(1):84-8. doi: 10.1016/s1072-7515(99)00226-4.
PubMed 10625237Shoji T, Tsubakihara Y, Fujii M, Imai E. Hemodialysis-associated hypotension as an independent risk factor for two-year mortality in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1212-20. doi: 10.1111/j.1523-1755.2004.00812.x.
PubMed 15327420Tisler A, Akocsi K, Harshegyi I, Varga G, Ferenczi S, Grosz M, Kulcsar I, Locsey L, Samik J, Solt I, Szegedi J, Toth E, Wagner G, Kiss I. Comparison of dialysis and clinical characteristics of patients with frequent and occasional hemodialysis-associated hypotension. Kidney Blood Press Res. 2002;25(2):97-102. doi: 10.1159/000063515.
PubMed 12077491Pillon L, Piccoli A, Lowrie EG, Lazarus JM, Chertow GM. Vector length as a proxy for the adequacy of ultrafiltration in hemodialysis. Kidney Int. 2004 Sep;66(3):1266-71. doi: 10.1111/j.1523-1755.2004.00881.x.
PubMed 15327426Movilli E, Gaggia P, Zubani R, Camerini C, Vizzardi V, Parrinello G, Savoldi S, Fischer MS, Londrino F, Cancarini G. Association between high ultrafiltration rates and mortality in uraemic patients on regular haemodialysis. A 5-year prospective observational multicentre study. Nephrol Dial Transplant. 2007 Dec;22(12):3547-52. doi: 10.1093/ndt/gfm466. Epub 2007 Sep 21.
PubMed 17890254Chamney PW, Kramer M, Rode C, Kleinekofort W, Wizemann V. A new technique for establishing dry weight in hemodialysis patients via whole body bioimpedance. Kidney Int. 2002 Jun;61(6):2250-8. doi: 10.1046/j.1523-1755.2002.00377.x.
PubMed 12028467Ozkahya M, Ok E, Toz H, Asci G, Duman S, Basci A, Kose T, Dorhout Mees EJ. Long-term survival rates in haemodialysis patients treated with strict volume control. Nephrol Dial Transplant. 2006 Dec;21(12):3506-13. doi: 10.1093/ndt/gfl487. Epub 2006 Sep 25.
PubMed 17000733Agarwal R, Alborzi P, Satyan S, Light RP. Dry-weight reduction in hypertensive hemodialysis patients (DRIP): a randomized, controlled trial. Hypertension. 2009 Mar;53(3):500-7. doi: 10.1161/HYPERTENSIONAHA.108.125674. Epub 2009 Jan 19.
PubMed 19153263Charra B. Fluid balance, dry weight, and blood pressure in dialysis. Hemodial Int. 2007 Jan;11(1):21-31. doi: 10.1111/j.1542-4758.2007.00148.x.
PubMed 17257351Moissl UM, Wabel P, Chamney PW, Bosaeus I, Levin NW, Bosy-Westphal A, Korth O, Muller MJ, Ellegard L, Malmros V, Kaitwatcharachai C, Kuhlmann MK, Zhu F, Fuller NJ. Body fluid volume determination via body composition spectroscopy in health and disease. Physiol Meas. 2006 Sep;27(9):921-33. doi: 10.1088/0967-3334/27/9/012. Epub 2006 Jul 25.
PubMed 16868355van den Ham EC, Kooman JP, Christiaans MH, Nieman FH, Van Kreel BK, Heidendal GA, Van Hooff JP. Body composition in renal transplant patients: bioimpedance analysis compared to isotope dilution, dual energy X-ray absorptiometry, and anthropometry. J Am Soc Nephrol. 1999 May;10(5):1067-79. doi: 10.1681/ASN.V1051067.
PubMed 10232694
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Long Term Effect of BCM Guided Fluid Management in MHD Patients
- ClinicalTrials.gov ID
- NCT01509937
- Acronym / sponsor ID
- BOCOMO / BOCOMO525
- Conditions
- End Stage Renal Disease
- Keywords
- end stage renal disease, maintenance hemodialysis, dry weight, bioimpedance spectroscopy analysis, body composition monitor, Fresenius BCM, Ultrafiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Fresenius Medical Care (Shanghai) Co., Ltd
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Jan 2012 (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.
It is hypothesized that bioimpedance spectroscope guided fluid management will help patient reach euvolemic status, and increase long term survival.
Background: Bioimpedance analysis (BIA) was helpful in identifying hypervolemia. Observational data using BIA methods showed that hypervolemic patients on maintenance hemodialysis (MHD) suffered from high mortality risk. But it is not clear if BIA guided fluid management can improve MHD patients' survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management comparing with standard care.
Design: This is a multicenter, prospective, randomized, controlled trial. Setting and Participants: More than 1300 participants from 16 clinical sites will be included in the study. The enrollment period will last 6 months, and minimum length of follow-up will not less than 36 months. MHD patients aged more than 18 years but less than 80 years who had been on MHD for at least 3 months and considered suitable candidates will be invited to participate in the study. Participants will be randomized to BIA arm or control arm using 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM-Fresenius Medical Care D GmbH) will be used for BIA measurement at baseline for both arm, and every 2 months in BCM arm.
Predictors: BCM guided fluid management and fluid management using standard care.
Outcome and measurements: The primary intent-to-treat analysis compares composite endpoint between BCM arm and control arm. The secondary intent-to-treat analysis compares left ventricular thickness, blood pressure, medication, and incidence and length of hospitalization between BCM arm and control arm. Death, acute myocardial infarction, stroke, peripheral arterial disease will be used as composite endpoint.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCM Arm | Experimental | Device: body bioimpedance spectroscopy deviceBCM measured every 2 months |
| Control arm | Sham comparator | Device: Devicepatients care according to standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosis of end stage renal disease (ESRD) and need MHD
- age of 18 years or older but 80 years or less
- on MHD for at least 3 months
- dialysis frequency of at least 5 sessions per 2 weeks, not less than 4 hours per session, Kt/V at least 1.2
- urine volume less than 800mL per 24 hours the day before dialysis session,
Key exclusion criteria (12 listed)
- acute infection within 1 month
- active rheumatic disease, or current on cortical steroid medication or cytotoxic medication
- uncontrolled neoplasm
- acute myocardial infarction within 1 month
- congestive heart failure (NYHA 3 - 4)
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 |
|---|---|---|
| body bioimpedance spectroscopy deviceName of the device is BCM from Fresenius Medical Care D GmbH | Device | BCM Arm |
| Deviceparticipants in control arm will not receive BCM measurement. | Device | Control arm |
Primary outcome
Incidence of composite endpoint
Time frame: during 36 months
Death, acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, peripheral arterial disease will be used as composite endpoint.
4 secondary outcomes
Change from baseline in Left ventricular thickness once a year
Time frame: baseline, and once a year during the following 36 months
Change from baseline in Pre-dialysis blood pressure every 2 months
Time frame: baseline, every 2 months during the following 36 months
Change from baseline in anti-hypertensives DDD every 2 months
Time frame: Baseline, and every 2 months during the following 36 months
Incidence of all cause and congestive heart failure related hospitalization
Time frame: during the 36 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 24 Nov 2015.
- Background: PubMed 19131355Wizemann V, Wabel P, Chamney P, Zaluska W, Moissl U, Rode C, Malecka-Masalska T, Marcelli D. The mortality risk of overhydration in haemodialysis patients. Nephrol Dial Transplant. 2009 May;24(5):1574-9. doi: 10.1093/ndt/gfn707. Epub 2009 Jan 7.
- Background: PubMed 12164889Jansen MA, Hart AA, Korevaar JC, Dekker FW, Boeschoten EW, Krediet RT; NECOSAD Study Group. Predictors of the rate of decline of residual renal function in incident dialysis patients. Kidney Int. 2002 Sep;62(3):1046-53. doi: 10.1046/j.1523-1755.2002.00505.x.
- Background: PubMed 12035137Puskar D, Pasini J, Savic I, Bedalov G, Sonicki Z. Survival of primary arteriovenous fistula in 463 patients on chronic hemodialysis. Croat Med J. 2002 Jun;43(3):306-11.
- Background: PubMed 15153764Mizumasa T, Hirakata H, Yoshimitsu T, Hirakata E, Kubo M, Kashiwagi M, Tanaka H, Kanai H, Fujimi S, Iida M. Dialysis-related hypotension as a cause of progressive frontal lobe atrophy in chronic hemodialysis patients: a 3-year prospective study. Nephron Clin Pract. 2004;97(1):c23-30. doi: 10.1159/000077592.
- Background: PubMed 10625237John AS, Tuerff SD, Kerstein MD. Nonocclusive mesenteric infarction in hemodialysis patients. J Am Coll Surg. 2000 Jan;190(1):84-8. doi: 10.1016/s1072-7515(99)00226-4.
- Background: PubMed 15327420Shoji T, Tsubakihara Y, Fujii M, Imai E. Hemodialysis-associated hypotension as an independent risk factor for two-year mortality in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1212-20. doi: 10.1111/j.1523-1755.2004.00812.x.
- Background: PubMed 12077491Tisler A, Akocsi K, Harshegyi I, Varga G, Ferenczi S, Grosz M, Kulcsar I, Locsey L, Samik J, Solt I, Szegedi J, Toth E, Wagner G, Kiss I. Comparison of dialysis and clinical characteristics of patients with frequent and occasional hemodialysis-associated hypotension. Kidney Blood Press Res. 2002;25(2):97-102. doi: 10.1159/000063515.
- Background: PubMed 15327426Pillon L, Piccoli A, Lowrie EG, Lazarus JM, Chertow GM. Vector length as a proxy for the adequacy of ultrafiltration in hemodialysis. Kidney Int. 2004 Sep;66(3):1266-71. doi: 10.1111/j.1523-1755.2004.00881.x.
- Background: PubMed 17890254Movilli E, Gaggia P, Zubani R, Camerini C, Vizzardi V, Parrinello G, Savoldi S, Fischer MS, Londrino F, Cancarini G. Association between high ultrafiltration rates and mortality in uraemic patients on regular haemodialysis. A 5-year prospective observational multicentre study. Nephrol Dial Transplant. 2007 Dec;22(12):3547-52. doi: 10.1093/ndt/gfm466. Epub 2007 Sep 21.
- Background: PubMed 12028467Chamney PW, Kramer M, Rode C, Kleinekofort W, Wizemann V. A new technique for establishing dry weight in hemodialysis patients via whole body bioimpedance. Kidney Int. 2002 Jun;61(6):2250-8. doi: 10.1046/j.1523-1755.2002.00377.x.
- Background: PubMed 17000733Ozkahya M, Ok E, Toz H, Asci G, Duman S, Basci A, Kose T, Dorhout Mees EJ. Long-term survival rates in haemodialysis patients treated with strict volume control. Nephrol Dial Transplant. 2006 Dec;21(12):3506-13. doi: 10.1093/ndt/gfl487. Epub 2006 Sep 25.
- Background: PubMed 19153263Agarwal R, Alborzi P, Satyan S, Light RP. Dry-weight reduction in hypertensive hemodialysis patients (DRIP): a randomized, controlled trial. Hypertension. 2009 Mar;53(3):500-7. doi: 10.1161/HYPERTENSIONAHA.108.125674. Epub 2009 Jan 19.
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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.
Li Zuo, MD & PhD study director
Institute of Nephrology, Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing body bioimpedance spectroscopy device and Device in people with End Stage Renal Disease, run by Peking University First Hospital at 1 site in China.
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 8 inclusion and 12 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 24 Nov 2015. 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 China. 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. Some participants in this study may receive a placebo. 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?
Incidence of composite endpoint (time frame: during 36 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 NCT01509937, which also lists 22 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 24 Nov 2015.