An observational study in End Stage Renal Disease (ESRD) and Volume Overload, sponsored by Massachusetts General Hospital. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Massachusetts General Hospital · Observational
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.
2,086 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 400 is above the median of 120 across 432 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Massachusetts General Hospital is the lead sponsor of 2,537 studies on the registry; 447 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
All adult (≥18 years) maintenance hemodialysis-dependent ESRD patients hospitalized for or with volume overload at either MGH or BWH
Meet the following previously published criteria for volume overload:
a) 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
Exclusion Criteria:
Patients from hospital where relative blood volume monitoring for inpatient hemodialysis sessions
Device: Relative Blood Volume Monitoring (RBVM)
Patients from hospital where relative blood volume monitoring not applied for inpatient hemodialysis sessions
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.
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
Time frame: From the date of hospitalization to the date of discharge whichever comes first assessed up to 365 days
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
Time frame: From date of discharge until 90 days post date of discharge of index hospitalization
Rates of Complications
Compare the rates of complications according to relative blood volume monitoring (RBVM) application versus no RBVM application among maintenance hemodialysis patients hospitalized for or with volume overload
Time frame: Rate of complications assessed over the period extending from the date of hospitalization to the date of discharge whichever comes first assessed up to 365 days
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Massachusetts General Hospital