HDF Clearance by Diffusion and Convection

Transcription

1 Hemodiafiltratio Improves Cardiovascular Risk Profile Compared to Covetioal Hemodialysis i Childre: the, Heart ad Height (H) Trial Rukshaa Shroff, Claus P. Schmitt, Fraz Schaefer Great Ormod Street Hospital for Childre, Lodo, UK Heidelberg Uiversity Ceter for Pediatrics ad Adolescet Medicie, Germay Clearace by Diffusio ad Covectio Low mol wt removal Middle mol wt removal Reduced Cardiovascular ad AllCause Mortality i Adults Udergoig vs Spaish (ESHOL) study CONTRAST study Turkish study,, Hazard Ratio,8,6,4 p=.6,, lowflux < 5.5 L 5.5. L olie >. L Switchig 8 patiets from to prevets oe death per year

2 Improved Growth o olie NOTE: High covective volume Daily Growth hormoe Fischbach et al; NDT, H: The, Heart ad Height Study Hypothesis Childre o compared with have improved: Ø Ø Ø Cardiovascular risk profile Growth ad utritioal status Quality of life Primary outcome measures: Ø Chage i carotid itima media thickess (cimt) SDS Ø Chage i height SDS Trial Desig Iclusio criteria Exclusio Treatmet strategies Assigmet Followup Aalysis pla Age 4 years (icidet ad prevalet dialysis patiets) Dialysis frequecy times / week Prevalet ad patiets must achieve a sigle pool Kt/v>. i the moth precedig recruitmet Livig door kidey trasplat plaed withi 6 moths Highflux or postdilutioal ; prescriptio sstadardized for target covectio volume 5L/m Noradomised moths 6mothly blood tests, aual vascular scas cimt, PWV, ECHO (cetral traiig ad 6mothly validatio) Perprotocol aalysis (>9% dialysis sessios i assiged group)

3 Trial Desig Pragmatic cliical trial ested withi the Iteratioal Pediatric Hemodialysis Network Registry 4C 6mothly blood tests, aual vascular scas IPHN cimt, PWV, ECHO (Cetral traiig ad 6mothly validatio for all operators) Numbers eeded 5 childre (75 i each study arm) 9% power, ad accoutig for % dropouts (Iterim aalysis at 8 moths oted a higher dropout i group, so recruitmet period was exteded by 5 moths with 5 ew cetres joiig) Recruitmet 9 childre recruited 8 ceters i coutries Recruitmet Flow Chart 9 childre recruited excluded Reasos for exclusio Age <4 years Dialysis frequecy < or >/wk Dialysis duratio <4hrs/sessio Predilutioal Trasplated o day of study = =6 = = = 79 etered study 6 7 year followup 78 (74%) 57 Loss to followup = 44 Trasplated = 5 (79%) Trasitioed = 5 Moved cetres = Missig data = No deaths (78%)

4 Demographics & Dialysis Characteristics (%) or Media (IQR) (%) or Media (IQR) (.8) 7 (4.6) 4 (4.6) (4.) (.) 4 (4.9) 9 (.9) (57.) (4.) 6 (.5) (.9) (5.7) (.4) (5.4).57 6 (64) 6 () 4 (5) (7, 5) (8 )/ (4) / (56) 8 (, ). (.4 4.5).5 Number Age Geder Female Uderlyig real diagosis CAKUT Glomeruloephritis Cystic kidey disease Residual real fuctio (urie vol ml) < 5 >5 Time o dialysis before study (moths) Vascular access AVF / AVG / CVL Blood flow rate (per m BSA) Covective volume (L/m/sessio) 55 (7) 8 () (7) 4.5 (8, 5) 8 (6) / () / 49 (6) 9 (58, 5) P Cardiovascular Measures at year ( = 78) ( = 57) mea (SD) mea (SD) cimt (mm).5 (.7).47 (.7). (SDS).64 (.44).88 (.68) (.) 5.9 (.86).8.97 (.).76 (.76).7 Left vetricular Mass Idex 48.7 (4.4) 6.7 (.) <. Iterdialytic weight gai (%) 4.95 (.4).9 (.94) <. 4hour Mea Arterial Pressure (mmhg) 96.6 (.) 88. (9.). PWV (m/sec) (SDS) p Chage i Cardiovascular Markers at year ( = 78) ( = 57) Chage from study etry Mea (SD) Mea (SD) cimt (mm). (.). (.).9 cimt SDS.48 (.79). (.84).8 PWV (m/sec). (.7).4 (.68).6 PWV SDS.4 (.45). (.9).5 Left Vetricular Mass Idex.78 (4.).84 (7.76)..6 (.84). (.69) (5.5). (.9).8 Iterdialytic weight gai (%) 4hour Mea Arterial Pressure SDS p 4

5 cimt SDS at Baselie ad year p =.8 p =.6 Predictors of cimt SDS p =. p =.89 vs group p =. PTH level p =. carotid itima media thickess stadard deviatio score Dialysate water quality p <. (ultrapure vs pure) Mea arterial pressure p <. Baselie Followup Baselie Followup halts the progressio of cimt Adjusted Aalysis Adjustmet for potetial cofouders performed usig propesity score approach Factors that might ifluece or choice based o cliical experiece: age, geder, coutry, blood flow ad water quality patiets had a greater icrease i cimt SDS of +.6 (95%CI +.5 to.66; p =.) compared to Chage i Height SDS p =.4 p =. p =. Chage i height SDS Height SDS p =.7. p = Baselie Followup Baselie Followup 5

6 Limitatios Pragmatic cliical trial withi the IPHN Registry Noradomised, ot blided Surrogate edpoits oly Partly idustry fuded No health ecoomic aalysis Cetral aalysis of biochemical markers ogoig SWITCH STUDY moths High flux Blood samplig Blood samplig moths (CV 5 L/m BSA) ühigher atioxidat capacity p=<. Blood samplig ülower iflammatio (ßM, hscrp) p=<. p=. ßM (mg/l) 5 4 p=.5 p=. RRF() RRF(+) TAC (mmol/l) ßM (mg/l) hscrp (mg(l) ü Lower edothelial dysfuctio markers (oxldl,adma, SDMA, AGEs) OxidizedLDL (g/ml) p=. ADMA (µmol/l) p=. SDMA (µmol/l) p=. AGEs (g/ml) p=. Coclusios I childre, halts the progressio of vascular chages compared to covetioal This may be due to improved fluid cotrol ad reduced iflammatio Detailed biochemical aalyses are ogoig 6

7 Ackowledgemets Collaborators: A. Bayazit (Adaa); A. Duzova (Akara Hacettepe ); S. Bakkaloglu (Akara Gazi); C. Stefaidis & V. Askiti (Athes); B. Spasojevic (Belgrade); S Stephes (Birmigham); W. Hayes (Bristol); S. Hegde (Cardiff); S. Habbig (Cologe); R. Buescher (Esse); K. Ažukaitis, D. BorzychDużałka, C. Schmitt & F. Schaefer (Heidelberg); S. Çaliska, N. Capolat, & A Yilmaz (Istabul); S. Mir (Izmir); C. Samaille (Lille); D. Bhowruth, M. Mayes, C. Smith (Lodo GOSH); M. Siha (Lodo ECH); B. Rachi (Lyo); M. Sheoy (Machester); F Paglialoga (Mila); E. Vidal (Padova); B. Ao (Paris Armad Trousseau) ; S. Krid (Paris Necker); K. Vodrák (Prague); M. Fischbach (Strasbourg); S. Picca (Rome); C. Licht (Toroto); M. Litwi (Warsaw). Iteratioal Pediatric Hemodialysis Network 7