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临床试验/NCT00529139
NCT00529139已完成4 期

The Hannover-Dialysis-Outcome (HAN-D-OUT)-Study: Comparison of Standard Versus Intensified Extended Dialysis in Treatment of Patients With Acute Kidney Injury in the Intensive-Care Unit

Hannover Medical School2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2003年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
157
试验地点
2
主要终点
Survival

研究概览

简要总结

Mortality rates of patients with acute kidney injury in the intensive care unit have changed little over the past few decades despite significant advances in supportive care. Few interventions have been shown to result in an improvement of in-hospital mortality of these patients, with dose of renal replacement therapy (RRT) being one of the most important. Patients undergoing continuous veno-venous hemofiltration had better outcomes with ultrafiltration rates of 35 mL/kg/h or 45 mL/kg/h than those treated at a rate of 20 mL/kg/h. In a different trial, intermittent hemodialysis on a daily basis resulted in better control of uremia, fewer hypotensive episodes during dialysis, and more rapid resolution of acute renal failure than thrice weekly hemodialysis. In the present study we examine survival and renal recovery in critically ill patients with acute kidney injury that are treated with a currently recommended (standard) dose of RRT, and patients that receive intensified RRT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non post-renal AKI with RRT dependency indicated by oliguria/anuria <30mL/h >6 hours prior to inclusion
  • loss of kidney function of >30% within 48 hours prior to inclusion
  • hyperkalemia >6.5 mmol/L
  • severe acidosis with pH<7.15

排除标准

  • pre-existing chronic kidney disease (CKD) as defined by an estimated glomerular filtration rate <50mL/min or a plasma creatinine concentration >1.7 mg/dL (>150 µmol/L) more than 10 days prior to initiation of the first RRT
  • presence of AV-fistula or dialysis catheter
  • participation in another study
  • consent denial or withdrawal
  • need for extra corporal membrane oxygenation therapy.

结局指标

主要结局

Survival

时间窗: Day 14 after initiation of renal replacement therapy

次要结局

  • Survival and renal recovery(Day 28 after initiation of renal replacement therapy)

研究者

申办方类型
Other

研究点 (2)

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