End Stage Renal Disease (ESRD)NCT07866872

Blood Volume Monitoring Via Critline in Volume Overload: Hospitalization and Readmission

An observational study of End Stage Renal Disease (ESRD) and Volume Overload, run by Massachusetts General Hospital at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

The investigators are examining how adding relative blood volume monitoring (RBVM) to the best clinical practice affects outcomes (length of stay and rehospitalization) among dialysis patients hospitalized for or with volume overload. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease (ESRD), Volume Overload
What is being tested?: Relative Blood Volume Monitoring (RBVM)
Type of treatment: Injection or infusion, Medical device
How many people: 400 participants
Where: 2 sitesUnited States
Study dates: 17 Jun 2026to Jun 2027
Phase: Observational
Are there results?: Not yet: the study is under way

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: All adult (≥18 years) maintenance hemodialysis-dependent ESRD patients hospitalized for or with volume overload at either MGH or BWH

Who may be able to join

Maintenance hemodialysis dependent ESRD patients hospitalized for or with volume overload at either MGH or BWH
Received at least one hemodialysis session during the index hospitalization
Meet the following previously published criteria for volume overload:
Clinical impression of volume overload and/or an acute heart failure exacerbation, or b) Respiratory compromise defined as subjective dyspnea or presenting oxygen saturation <92% on room air plus >2 of the following signs: i) Jugular venous distension, ii) Third heart sound, iii) Bibasilar lung rales or crackles, iv) Pulmonary edema on chest imaging, v) Reported bilateral pulmonary infiltrates on chest imaging without fever, vi) Reported pleural effusion on chest imaging, vii) Reported abdominal ascites on abdominal imaging, viii) Documented central venous pressure >12 mmHg, ix) Documented pulmonary capillary wedge pressure >12 mmHg

Who cannot join

Patients with acute kidney injury requiring dialysis
Patients hospitalized for the initiation of hemodialysis
Patients requiring continuous kidney replacement therapy at admission
Patients under observation status
Patients with liver cirrhosis

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Conditions: End Stage Renal Disease (ESRD), Volume Overload
Being tested: Relative Blood Volume Monitoring (RBVM)
Keywords: End Stage Renal Disease, Volume Overload, Inpatient Dialysis, Relative Blood Volume Monitoring (RBVM), Crit Line
Medical subject headings: Kidney Failure, Chronic, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Relative Blood Volume Monitoring (RBVM)Device
The intervention of interest for this prospective study is guidance obtained by relative blood volume monitoring (RBVM) using the Crit-Line IV Monitor or CLiC device. The application of RBVM versus no application of RBVM during inpatient hemodialysis sessions will be according to the standard of care at the participating hospital.

Study groups in NCT07866872
Study group	Role	What they receive
RBVM patients		Patients from hospital where relative blood volume monitoring for inpatient hemodialysis sessions Receives: Device: Relative Blood Volume Monitoring (RBVM)
Non RBVM Patients		Patients from hospital where relative blood volume monitoring not applied for inpatient hemodialysis sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

Length of Index Hospitalization
The length of index hospitalizations stay will be used to compare relative blood volume monitoring application (RBVM) versus no RBVM application among maintenance hemodialysis patients hospitalized for or with volume overload
Measured: From the date of hospitalization to the date of discharge whichever comes first assessed up to 365 days

Secondary outcomes (1)

90 Day Rehospitalization Rate
Compare rehospitalization rates according to relative blood volume monitoring application (RBVM) versus no RBVM application among maintenance hemodialysis patients hospitalized for or with volume overload within 90 days of index discharge
Measured: From date of discharge until 90 days post date of discharge of index hospitalization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 2026Jun 2027

First posted8 Oct 2026
Study start17 Jun 2026
Primary completionJun 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
More trials run by Massachusetts General 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07866872
Sponsor's protocol ID: 2024P003473
Status last verified: Oct 2026
First submitted: 29 Sep 2026
Last updated: 8 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Ficociello, L., Zhou, M., Han, H., Anger, M. S., & Hymes, J. L. (2023). Relative Blood Volume Monitoring Using Crit-Line and Hospital Admissions: A Retrospective Analysis of over 25,000 Patients Across 330 Dialysis Clinics: TH-PO245. Journal of the American Society of Nephrology, 34(11S), 158. https://doi.org/10.1681/ASN.20233411S1158b
Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM. Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol. 2015 Mar;26(3):724-34. doi: 10.1681/ASN.2014020222. Epub 2014 Sep 30.
PubMed 25270068
Antlanger M, Josten P, Kammer M, Exner I, Lorenz-Turnheim K, Eigner M, Paul G, Klauser-Braun R, Sunder-Plassmann G, Saemann MD, Hecking M. Blood volume-monitored regulation of ultrafiltration to decrease the dry weight in fluid-overloaded hemodialysis patients: a randomized controlled trial. BMC Nephrol. 2017 Jul 17;18(1):238. doi: 10.1186/s12882-017-0639-x.
PubMed 28716046
Rodriguez HJ, Domenici R, Diroll A, Goykhman I. Assessment of dry weight by monitoring changes in blood volume during hemodialysis using Crit-Line. Kidney Int. 2005 Aug;68(2):854-61. doi: 10.1111/j.1523-1755.2005.00467.x.
PubMed 16014066
Leung KCW, Quinn RR, Ravani P, Duff H, MacRae JM. Randomized Crossover Trial of Blood Volume Monitoring-Guided Ultrafiltration Biofeedback to Reduce Intradialytic Hypotensive Episodes with Hemodialysis. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1831-1840. doi: 10.2215/CJN.01030117. Epub 2017 Oct 10.
PubMed 29018100
Deziel C, Bouchard J, Zellweger M, Madore F. Impact of hemocontrol on hypertension, nursing interventions, and quality of life: a randomized, controlled trial. Clin J Am Soc Nephrol. 2007 Jul;2(4):661-8. doi: 10.2215/CJN.04171206. Epub 2007 Apr 25.
PubMed 17699479
Begin V, Deziel C, Madore F. Biofeedback regulation of ultrafiltration and dialysate conductivity for the prevention of hypotension during hemodialysis. ASAIO J. 2002 May-Jun;48(3):312-5. doi: 10.1097/00002480-200205000-00018.
PubMed 12059007
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. doi: 10.1046/j.1523-1755.2002.00511.x.
PubMed 12164888
McIntyre CW, Lambie SH, Fluck RJ. Biofeedback controlled hemodialysis (BF-HD) reduces symptoms and increases both hemodynamic tolerability and dialysis adequacy in non-hypotension prone stable patients. Clin Nephrol. 2003 Aug;60(2):105-12. doi: 10.5414/cnp60105.
PubMed 12940612
Martin M, Bansal A, Perez L, Stenson EK, Kendrick J. Use of Relative Blood Volume Monitoring to Reduce Intradialytic Hypotension in Hospitalized Patients Receiving Dialysis. Kidney Int Rep. 2022 Jul 4;7(9):2105-2107. doi: 10.1016/j.ekir.2022.06.018. eCollection 2022 Sep. No abstract available.
PubMed 36090491
Reddan DN, Szczech LA, Hasselblad V, Lowrie EG, Lindsay RM, Himmelfarb J, Toto RD, Stivelman J, Winchester JF, Zillman LA, Califf RM, Owen WF Jr. Intradialytic blood volume monitoring in ambulatory hemodialysis patients: a randomized trial. J Am Soc Nephrol. 2005 Jul;16(7):2162-9. doi: 10.1681/ASN.2004121053. Epub 2005 Jun 1.
PubMed 15930095
Balter P, Ficociello LH, Taylor PB, Usvyat L, Sawin DA, Mullon C, Diaz-Buxo J, Zabetakis P. A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis. Curr Med Res Opin. 2015;31(7):1323-31. doi: 10.1185/03007995.2015.1047746. Epub 2015 Jun 3.
PubMed 25942380
Dasselaar JJ, Huisman RM, de Jong PE, Franssen CF. Measurement of relative blood volume changes during haemodialysis: merits and limitations. Nephrol Dial Transplant. 2005 Oct;20(10):2043-9. doi: 10.1093/ndt/gfi056. Epub 2005 Aug 16. No abstract available.
PubMed 16105867
Assimon MM, Nguyen T, Katsanos SL, Brunelli SM, Flythe JE. Identification of volume overload hospitalizations among hemodialysis patients using administrative claims: a validation study. BMC Nephrol. 2016 Nov 11;17(1):173. doi: 10.1186/s12882-016-0384-6.
PubMed 27835958
Saffer T, Mesiwala A. Systematic CKD Care Approaches: A Potential Solution for the Costly ESRD Program. Kidney Med. 2022 Dec 9;5(2):100581. doi: 10.1016/j.xkme.2022.100581. eCollection 2023 Feb.
PubMed 36686594

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All End Stage Renal Disease (ESRD) trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood Volume Monitoring Via Critline in Volume Overload: Hospitalization and Readmission
ClinicalTrials.gov ID: NCT07866872
Acronym / sponsor ID: 2024P003473
Conditions: End Stage Renal Disease (ESRD), Volume Overload
Keywords: End Stage Renal Disease, Volume Overload, Inpatient Dialysis, Relative Blood Volume Monitoring (RBVM), Crit Line
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 400 participants (estimated)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 17 Jun 2026 (actual)
Primary completion: Jun 2027 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 8 Oct 2026 (actual)
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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
RBVM patients	–	Device: Relative Blood Volume Monitoring (RBVM)Patients from hospital where relative blood volume monitoring for inpatient hemodialysis sessions
Non RBVM Patients	–	–Patients from hospital where relative blood volume monitoring not applied for inpatient hemodialysis sessions

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All adult (≥18 years) maintenance hemodialysis-dependent ESRD patients hospitalized for or with volume overload at either MGH or BWH

Key inclusion criteria (4 listed)

Maintenance hemodialysis dependent ESRD patients hospitalized for or with volume overload at either MGH or BWH
Received at least one hemodialysis session during the index hospitalization
Meet the following previously published criteria for volume overload:

Key exclusion criteria (5 listed)

Patients with acute kidney injury requiring dialysis
Patients hospitalized for the initiation of hemodialysis
Patients requiring continuous kidney replacement therapy at admission
Patients under observation status
Patients with liver cirrhosis

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
Relative Blood Volume Monitoring (RBVM)The intervention of interest for this prospective study is guidance obtained by relative blood volume monitoring (RBVM) using the Crit-Line IV Monitor or CLiC device. The application of RBVM versus no application of RBVM during inpatient hemodialysis sessions will be according to the standard of care at the participating hospital.	Device	RBVM patients

Primary outcome

Length of Index Hospitalization
Time frame: From the date of hospitalization to the date of discharge whichever comes first assessed up to 365 days
The length of index hospitalizations stay will be used to compare relative blood volume monitoring application (RBVM) versus no RBVM application among maintenance hemodialysis patients hospitalized for or with volume overload

1 secondary outcome

90 Day Rehospitalization Rate
Time frame: From date of discharge until 90 days post date of discharge of index hospitalization

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
BackgroundFicociello, L., Zhou, M., Han, H., Anger, M. S., & Hymes, J. L. (2023). Relative Blood Volume Monitoring Using Crit-Line and Hospital Admissions: A Retrospective Analysis of over 25,000 Patients Across 330 Dialysis Clinics: TH-PO245. Journal of the American Society of Nephrology, 34(11S), 158. https://doi.org/10.1681/ASN.20233411S1158b
Background: PubMed 25270068Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM. Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol. 2015 Mar;26(3):724-34. doi: 10.1681/ASN.2014020222. Epub 2014 Sep 30.
Background: PubMed 28716046Antlanger M, Josten P, Kammer M, Exner I, Lorenz-Turnheim K, Eigner M, Paul G, Klauser-Braun R, Sunder-Plassmann G, Saemann MD, Hecking M. Blood volume-monitored regulation of ultrafiltration to decrease the dry weight in fluid-overloaded hemodialysis patients: a randomized controlled trial. BMC Nephrol. 2017 Jul 17;18(1):238. doi: 10.1186/s12882-017-0639-x.
Background: PubMed 16014066Rodriguez HJ, Domenici R, Diroll A, Goykhman I. Assessment of dry weight by monitoring changes in blood volume during hemodialysis using Crit-Line. Kidney Int. 2005 Aug;68(2):854-61. doi: 10.1111/j.1523-1755.2005.00467.x.
Background: PubMed 29018100Leung KCW, Quinn RR, Ravani P, Duff H, MacRae JM. Randomized Crossover Trial of Blood Volume Monitoring-Guided Ultrafiltration Biofeedback to Reduce Intradialytic Hypotensive Episodes with Hemodialysis. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1831-1840. doi: 10.2215/CJN.01030117. Epub 2017 Oct 10.
Background: PubMed 17699479Deziel C, Bouchard J, Zellweger M, Madore F. Impact of hemocontrol on hypertension, nursing interventions, and quality of life: a randomized, controlled trial. Clin J Am Soc Nephrol. 2007 Jul;2(4):661-8. doi: 10.2215/CJN.04171206. Epub 2007 Apr 25.
Background: PubMed 12059007Begin V, Deziel C, Madore F. Biofeedback regulation of ultrafiltration and dialysate conductivity for the prevention of hypotension during hemodialysis. ASAIO J. 2002 May-Jun;48(3):312-5. doi: 10.1097/00002480-200205000-00018.
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 12940612McIntyre CW, Lambie SH, Fluck RJ. Biofeedback controlled hemodialysis (BF-HD) reduces symptoms and increases both hemodynamic tolerability and dialysis adequacy in non-hypotension prone stable patients. Clin Nephrol. 2003 Aug;60(2):105-12. doi: 10.5414/cnp60105.
Background: PubMed 36090491Martin M, Bansal A, Perez L, Stenson EK, Kendrick J. Use of Relative Blood Volume Monitoring to Reduce Intradialytic Hypotension in Hospitalized Patients Receiving Dialysis. Kidney Int Rep. 2022 Jul 4;7(9):2105-2107. doi: 10.1016/j.ekir.2022.06.018. eCollection 2022 Sep. No abstract available.
Background: PubMed 15930095Reddan DN, Szczech LA, Hasselblad V, Lowrie EG, Lindsay RM, Himmelfarb J, Toto RD, Stivelman J, Winchester JF, Zillman LA, Califf RM, Owen WF Jr. Intradialytic blood volume monitoring in ambulatory hemodialysis patients: a randomized trial. J Am Soc Nephrol. 2005 Jul;16(7):2162-9. doi: 10.1681/ASN.2004121053. Epub 2005 Jun 1.
Background: PubMed 25942380Balter P, Ficociello LH, Taylor PB, Usvyat L, Sawin DA, Mullon C, Diaz-Buxo J, Zabetakis P. A year-long quality improvement project on fluid management using blood volume monitoring during hemodialysis. Curr Med Res Opin. 2015;31(7):1323-31. doi: 10.1185/03007995.2015.1047746. Epub 2015 Jun 3.
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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Renal Disease (ESRD) and Volume Overload, run by Massachusetts General Hospital at 2 sites in United States.

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 5 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: enrolling by invitation, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Length of Index Hospitalization (time frame: From the date of hospitalization to the date of discharge whichever comes first assessed up to 365 days). 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 NCT07866872, which also lists 17 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 8 Oct 2026.