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临床试验/NCT04394780
NCT04394780已完成不适用

Pilot Study to Determine Whether Cooled Peritoneal Dialysis Fluid Confers Cardio-Protective Effects

Lawson Health Research Institute0 个研究点目标入组 8 人开始时间: 2016年1月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
主要终点
Correlation between occlusive coronary artery disease and myocardial perfusion

研究概览

简要总结

The study team aimed to investigate the relationship between occlusive coronary artery disease, myocardial perfusion, and peritoneal dialysate temperature. In addition, the study team aimed to identify how abnormal myocardial perfusion in peritoneal dialysis (PD) patients is related to occlusive coronary artery disease, to identify factors associated with occlusive coronary artery disease in end-stage renal failure patients on PD. Finally, the study team identified factors associated with PD induced cardiac injury in end-stage renal failure patients on this dialysis modality.

In order to assess the patients response to physiological stress and the functional relevance of their coronary artery disease, patients underwent assessment using dual energy contrast enhanced (DCE) CT assessment of coronary arteries and myocardial perfusion. An initial CT scan with administration of contrast established baseline information regarding the extent of coronary artery disease, fibrosis, and myocardial perfusion at rest. Following this, patients underwent pharmacological stress with the administration of adenosine and a repeat CT scan established the response to stress in terms of myocardial perfusion. On the second study visit patients were started on C-CAPD using peritoneal dialysate cooled to between 32-33 degrees centigrade, at a pre-determined and precisely controlled temperature for the 4 hour duration of C-CAPD. Subsequently, patients were injected with a pharmacological stressor in the form of adenosine. They then underwent DCE CT assessment of coronary arteries and myocardial perfusion as done in the first visit. The second CT scan took place following a PD dwell.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Patients having peritoneal dialysis treatment at least 6 times per week at home and followed at the London Health Sciences Centre
  • •Male and female, age=16 years old
  • •Patients listed for renal transplantation
  • •Residual renal function less than or equal to 750 mls per 24 hour period

排除标准

  • •Not meeting inclusion criteria
  • •Previous adverse reaction to intravenous contrast
  • •Allergy to adenosine - Patients with significant residual renal function (greater than 750mL/24 hours)
  • •Exposure to peritoneal dialysis for <90 days prior to recruitment
  • •Ongoing spontaneous bacterial peritonitis (SBP)
  • •Severe heart failure (New York Heart Association grade IV) - Cardiac transplant recipients
  • •Mental incapacity to consent

研究组 & 干预措施

Peritoneal dialysis at 37 C

No Intervention

Patients underwent peritoneal dialysis with the standard temperature.

Peritoneal dialysis at 32 C

Active Comparator

Patients started on continuous ambulatory peritoneal dialysis using a peritoneal dialysate cooled to between 32-33 degrees centigrade, at a pre-determined and precisely controlled temperature for the 4 hour duration treatment.

干预措施: cooling (Procedure)

结局指标

主要结局

Correlation between occlusive coronary artery disease and myocardial perfusion

时间窗: The day of study visit 2, lasting for approximately 6 hours

Investigate the correlation between occlusive coronary artery disease, myocardial perfusion and peritoneal dialysate temperature. Patients will have a CT scan to measure perfusion (mL/min/g) after peritoneal dialysis

Correlation between occlusive coronary artery disease and myocardial perfusion

时间窗: The day of study visit 1, lasting for approximately 2 hours

Investigate the correlation between occlusive coronary artery disease, myocardial perfusion, and peritoneal dialysate temperature. Patients will have a CT scan to measure perfusion (mL/min/g) after peritoneal dialysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chris McIntyre

Principal Investigator

Lawson Health Research Institute

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