A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study): rationales and study design

Table 1 BOCOMO study schedule of data collection

Item	Baseline frequency	Follow up frequency
Demographic information	Once	-
ESRD history¹	Once	-
Comorbidity²	Once	-
Physical examination³	Once	Every 2 months
Timed urine collection⁴	Once	Every 2 months
CBC⁵	Once	Every 3 months
Routine laboratory data⁶	Once	Every 3 months
Kt/V	Once	Every 3 months
iPTH	Once	Every 3 months
hsCRP	Once	Every 3 months
UCG	Once	Every 12 months
BCM measurement	Once	Every 2 months in BCM arm
Dialysis prescription change⁷	Once	Throughout the study period
Medication change⁸	Once	Throughout the study period
New clinical event⁹	-	Throughout the study period

Abbreviation: BOCOMO study, body composition monitor study; ESRD, end stage renal disease; CBC, complete blood count; Kt/V, calculated using Daugirdas single pool equation; iPTH, intact parathyroid hormone; hsCRP, high sensitive C-reactive protein; UCG, ultrasonic cardiograph.
¹ESRD history includes cause of ESRD, date of first dialysis, type of vascular access.
²Detailed history of comorbidity will be assessed, including vascular access events.
³Physical examination includes body weight, blood pressure, heart rate, edema, pulmonary rale, before and after hemodialysis session.
⁴24 hours urine volume collected the day before dialysis session will be recorded.
⁵Consists of hemoglobin, white blood cell count, platelet count.
⁶Consists of albumin, pre-Albumin, creatinine, urea, potassium, sodium, chloride, calcium, phosphate, bicarbonate, alkaline phosphatase (ALP), glucose, triglycerides, total cholesterol, low density lipoprotein, high density lipoprotein, brain natriuretic peptide (BNP).
⁷Any dialysis prescription change throughout the study period will be recorded.
⁸Any medication change throughout the study period will be recorded.
⁹Any new clinical event throughout the study period will be recorded, including hospitalization, new diagnosis, vascular access related event, treatment of abnormal laboratory value, dry weight adjustment.

ISSN: 1471-2369