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.
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
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
About this study
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sagar U. Nigwekar, MD, MMSc, Massachusetts General Hospital
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 25270068Antlanger 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 28716046Rodriguez 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 16014066Leung 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 29018100Deziel 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 17699479Begin 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 12059007Santoro 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 12164888McIntyre 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 12940612Martin 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 36090491Reddan 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 15930095Balter 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 25942380Dasselaar 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 16105867Assimon 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 27835958Saffer 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