「Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure」 Peter J. Blankestijn, M.D et al, for the CONVINCE Scientific Committee Investigators June 16, 2023, N Engl J Med 2023;389:700-9.DOI: 10.1056
「Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure」
Peter J. Blankestijn, M.D et al, for the CONVINCE Scientific Committee Investigators June 16, 2023, N Engl J Med 2023;389:700-9.DOI: 10.1056
「Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol」, Peter J. Blankestijn, M.D et al, MJ Open 2020; 10(2): e033228.
「Benefits and harms of high-dose haemodiafiltration versus high-flux haemodialysis: the comparison of high-dose haemodiafiltration with high-flux haemodialysis (CONVINCE) trial protocol」
Peter J. Blankestijn, M.D et al, MJ Open 2020; 10(2): e033228.
体格とQB「Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure」 Peter J. Blankestijn, M.D et al, for the CONVINCE Scientific Committee Investigators June 16, 2023, N Engl J Med 2023;389:700-9.DOI: 10.1056
To evaluate the comparative efficacy of high-dose HDF and high-flux HD on all-cause and cause-specific death, fatal and non-fatal cardiovascular events, all-cause and cause-specific hospitalizations.
To evaluate the effect of high-dose HDF versus high- flux HD on patient-reported outcomes (PROs), particularly health-related quality of life.
To conduct a cost-effectiveness analysis for the two treatment modalities.
ランダム化の割付け:「Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure」 Peter J. Blankestijn, M.D et al, for the CONVINCE Scientific Committee Investigators June 16, 2023, N Engl J Med 2023;389:700-9.DOI: 10.1056
割り付けグループ
high – dose HDF群 → 683名
high – flux HD群 → 677名
治療条件は?
注目の治療条件ですが以下の通りです。
患者のベースラインデータも示しておきます。
患者ベースラインデータ:「Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure」 Peter J. Blankestijn, M.D et al, for the CONVINCE Scientific Committee Investigators June 16, 2023, N Engl J Med 2023;389:700-9.DOI: 10.1056
high – dose HDF群
high – dose HDF群の治療条件として、本文中に以下のように述べられています。
The trial inter- vention was high-dose hemodiafiltration with on-line production of substitution fluid and ultra- pure bicarbonate-based dialysis fluid at a con- vection volume of at least 23 liters per session in postdilution mode.
Convection volume (i.e., total ultrafiltration volume) is the sum of the substi- tution volume and the net ultrafiltration volume (i.e., the treatment-induced weight loss as calcu- lated to estimate dry weight).
治療条件早見表:「Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure」 Peter J. Blankestijn, M.D et al, for the CONVINCE Scientific Committee Investigators June 16, 2023, N Engl J Med 2023;389:700-9.DOI: 10.1056
high – flux HD群
high – flux HD群の治療条件について、本文中に以下のように述べられています。
The comparison group received conventional hemodialysis by means of high-flux dialysis membranes and ultrapure bicarbonatebased dialysis fluid.
※The control group will receive high-flux HD using high-flux dialysis membranes and ultrapure bicarbonate-based dialysis fluid as standard of dialysis care.
Peter J Blankestijn for the CONVINCE study groupのスライド資料より抜粋
Outcome
primary outcomeとsecondary outcomeを次に示します。
primary outcome
“The primary outcome was death from any cause.”
→ 全死亡率
secondary outcome
“Key secondary outcomes were cause-specific death, a composite of fatal or nonfatal cardiovascular events, kidney transplantation, and recurrent all-cause or infectionrelated hospitalizations.”
outcome一覧:「Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure」 Peter J. Blankestijn, M.D et al, for the CONVINCE Scientific Committee Investigators June 16, 2023, N Engl J Med 2023;389:700-9.DOI: 10.1056
:「Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure」 Peter J. Blankestijn, M.D et al, for the CONVINCE Scientific Committee Investigators June 16, 2023, N Engl J Med 2023;389:700-9.DOI: 10.1056
“Since all the patients had stage V disease, the trial population had a wide variety of frequent adverse events. Thus, the ethics com- mittee approved our request to restrict the report- ing of adverse events only to serious events regard- ing the primary and secondary outcomes. Findings with respect to patient-reported outcomes and cost-effectiveness are not reported here.”
“The lower mortal- ity can be partly attributed to selection by the treating physician to enroll patients who were likely to reach a convection volume of at least 23 liters during each session, an indication that these patients had relatively good vascular access.”
“However, our inclusion criteria may have resulted in a trial population that was healthier than the general hemodialysis population in Europe1 and in the United States24 (Section S8). Also, we did not collect data regarding race or ethnic group among our European patients, so our findings may not be generalizable to non- White patients with kidney failure.”
“In case of different substitution modality (pre, mid or mixed dilution) a correction factor (resp. 2 times higher – 1,5 times higher than in post dilution) will be applied to match the performance.”
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