Table 3.

Adverse Events for HD and HDF, Per Session

Variable	HD Sessions	HDF Sessions	RR (95% CI)	P	Data Available, %
Symptomatic hypotensiona	112 (5.2)	168 (8)	1.52 (1.21-1.92)	<0.001	97
AEs potentially related to BP/fluid shiftsb	61 (3.0)	109 (5.3)	1.81 (1.33-2.46)	<0.001	93
AEs not classically related to BP/fluid shiftsc	88 (4.3)	87 (4.3)	1.00 (0.75-1.34)	0.9	93
Extra tinzaparin dose(s) or clotting of circuitd	14 (0.7)	37 (1.8)	2.68 (1.46-5.00)	0.002	97

Note: Unless otherwise indicated, values are given as number of events (percentage). Multiple episodes within 1 session were treated as a single event. Odds ratios taking into account the crossover design were also calculated and were almost identical to RRs.

Abbreviations: AE, adverse event; BP, blood pressure; CI, confidence interval; HD, high-flux hemodialysis; HDF, hemodiafiltration; RR, relative risk.

^aDefined as a decrease in systolic BP ≥ 20 mm Hg requiring reduction or cessation of ultrafiltration and/or need for intravenous fluid bolus or head-down tilt of dialysis chair.

^bBreathlessness, cramp (normal BP), dizzy/lightheaded, fall, headache, venous pressures erratic, clotted needle, or restless legs.

^cAches in bones, arm pain, back pain, bleeding, constipation, diarrhea, feeling cold, feeling down, feeling hot, generally unwell, heavy legs, increased lethargy, infection (given antibiotics), itch, leg pain, nausea, stomach pains, sweating, swollen abdomen, and vomiting.

^dDefined as either an increase in venous pressure requiring additional anticoagulant dosing or clotting of the extracorporeal circuit.