跳至主要内容
临床试验/NCT00912184
NCT00912184已完成1 期

Pilot Randomised Controlled Study Comparing The Effect of High Cut-off Point Haemofiltration With Standard Haemofiltration In Patients With Acute Renal Failure

Austin Health1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2009年5月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
Austin Health
入组人数
76
试验地点
1
主要终点
The primary outcome measure for this study is noradrenaline free time in the first week after randomization

研究概览

简要总结

This trial aims to study the effect of combining continuous and a new polyamide membrane with larger pores in the treatment of critically ill patients with acute renal failure and low blood pressure (shock) requiring noradrenaline. The investigators wish to compare the clinical effect of this new therapy to that of haemofiltration with a standard membrane.

详细描述

During acute renal failure, small and middle molecular-weight toxins accumulate. These molecules are difficult to remove by standard haemofiltration. Accordingly, they accumulate and contribute to morbidity in long-term dialysis patients. Molecules such as cytokines have been shown to play a central pathogenic role in critical illness. In critically ill acute renal failure patients, they accumulate in serum and likely contribute to much morbidity (fever, low blood pressure, myocardial dysfunction, renal failure itself etc.) Therefore, the removal of cytokines appears desirable. Although different approaches have been undertaken, all have had limited success due to complexity, limited efficacy or uncertain clinical response [10-15].

It is possible that in using a different and more porous membrane, the removal of cytokines would be much more efficient and that clinical benefits of blood purification would, therefore, be greater.

A membrane of this kind is now available. It is a modification (moderate increase in pore size) of another standard material called polyamide, which has already been used in millions of people for dialysis and haemofiltration. The increased pore size of these new membranes is directed at a more effective removal of middle molecular-weight toxins such as cytokines.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •The treating clinician believes that the patient requires haemofiltration for acute renal failure
  • •The patient is on noradrenaline infusion for haemodynamic support
  • •The patient was commenced on noradrenaline or haemofiltration within the last 12 hours
  • •The clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with different membranes
  • •The treating clinicians anticipate treating the patient with haemofiltration for at least 72 hours
  • •Informed consent has been obtained
  • •The patient fulfils ONE of the following clinical criteria for initiating haemofiltration:
  • •Oliguria (urine output < 100 ml/6 hr) that has been unresponsive to fluid resuscitation measures.
  • •Hyperkalemia ([K+] > 6.5 mmol/L)
  • •Severe acidemia (pH < 7.2)
  • •Urea > 25 mmol/liter
  • •Creatinine > 300 mmol/L
  • •Clinically significant organ oedema in the setting of ARF (e.g., lung)

排除标准

  • •Patient age is < 18 years
  • •Death is imminent (< 24 hours)
  • •There is a strong likelihood that the study treatment would not be continued in accordance with the study protocol
  • •The patient has been treated with haemofiltration or other dialysis previously during the same hospital admission
  • •The patient was on maintenance dialysis prior to the current hospitalisation
  • •Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study
  • •The patient is pregnant or is breastfeeding
  • •The patient has previously been enrolled in this study

研究组 & 干预措施

1

Experimental

CVVH with high cut-off polyamide membrane (P2SH) using standard continuous veno-venous hemofiltration (CVVH) settings

干预措施: High cut-off (super high flux) polyamide membrane (Device)

2

Active Comparator

CVVH using standard high flux membrane with standard CVVH settings

干预措施: Standard polyamide high flux membrane (Device)

结局指标

主要结局

The primary outcome measure for this study is noradrenaline free time in the first week after randomization

时间窗: 24 months

次要结局

  • The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10(24 months)

研究者

发起方
Austin Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Rafidah Atan

PhD student

Austin Health

研究点 (1)

Loading locations...

相似试验