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Remote Ischemic Preconditioning After Cardiac Surgery (RIPCRenal)

2018年1月29日 更新者：University Hospital Muenster

Remote Ischemic Preconditioning to Prevent Acute Kidney Injury in High Risk Patients After Cardiac Surgery (RIPCRenal)

Acute kidney injury (AKI) is a well-recognized complication after cardiac surgery with cardiopulmonary bypass (CPB). The aim of this study is to reduce the incidence of AKI by implementing remote ischemic preconditioning and to evaluate the dose-response relationship using the biomarkers urinary [TIMP-2] *[IGFBP7] in high risk patients undergoing cardiac surgery.

研究概览

地位

未知

条件

干预/治疗

详细说明

Acute kidney injury (AKI) complicates 7-19% of cardiac surgical procedures. The investigators recently found that remote ischemic preconditioning (RIPC) using transient external compression of the upper arm prior to cardiac surgery was effective for reducing the occurrence of AKI (37.5% compared to 52.5% with sham; absolute risk reduction (ARR),15%; 95% CI, 2.56% to 27.44%; P=0.02). Fewer patients treated with RIPC received renal replacement therapy (RRT) (5.8% versus 15.8%; ARR, 10%; 95% CI, 2.25% to 17.75%; P=0.01). Moreover, the investigators found that the effectiveness of this intervention was strongly associated with the release of cell-cycle arrest biomarkers into the urine. Patients with urinary tissue inhibitor of metalloproteinases-2 and insulin-like growth factor-binding protein 7 ([TIMP-2]•[IGFBP7]) ≥ 0.5 (ng/ml)(ng/ml)/1000 before surgery had a significantly reduced rate of AKI compared to patients with lower urinary [TIMP-2]•[IGFBP7] concentration (relative risk (RR), 67%; 95% CI, 53% to 83%, P<0.001) whereas the biomarker concentrations after surgery predicted AKI as previously shown. This effect makes sense because cell-cycle arrest is thought to be part of the protective mechanisms endothelial cells use when exposed to stress. Stimulating these responses with RIPC should reduce AKI. Importantly, only 56% of patients treated with RIPC achieved an increase in urine [TIMP-2]•[IGFBP7] to ≥ 0.5, and only in this group was the intervention effective-patients that did not achieve this level showed no benefit.

Our goal is to eventually design and conduct a Bayesian 2-stage adaptive design sequence trial to evaluate the effectiveness of RIPC to prevent AKI in patients undergoing cardiac surgery. The dimensions of dose include duration, intensity and number of cycles. However, before this trial can be designed we need to answer 4 questions: i. Do baseline urinary [TIMP-2]•[IGFBP7] levels predict AKI (enrichment)? ii. Do [TIMP-2]•[IGFBP7] changes elicited by RIPC predict protection (RIPC efficacy measure)? iii. Is there a dose-response relationship between RIPC "dose" and [TIMP-2]•[IGFBP7]? iv. Is a dose-escalation RIPC protocol where doses are increased for non-responders, feasible and safe within the anesthesia workflow for cardiac surgery cases (practical)?

研究类型

介入性

注册 (预期的)

180

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
      • Muenster、德国、D-48149
        • 招聘中
        • University Hospital Muenster
        • 接触：
          • Alexander Zarbock, PhD, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients who are scheduled to undergo cardiac surgery with cardiopulmonary bypass
  • Cleveland Clinic Score >=6

Exclusion Criteria:

  • Acute myocardial infarction up to 7 days before surgery
  • Age < 18 years
  • Off-pump cardiac surgery
  • Preexisting AKI
  • Chronic kidney disease (GFR < 30 ml/min)
  • Kidney transplantation within the last 12 months
  • Peripheral arterial occlusive disease
  • Pregnancy
  • Hepatorenal syndrome
  • Sulfonamide or thiazide medication within the last 7 days
  • Participation in another interventional trial

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
无干预：Observational group
No intervention, standard care
假比较器：Sham RIPC
Three cycles of 5- min upper limb sham ischemia
程序：Remote ischemic preconditioning (RIPC)
3 cycles or more cycles of 5 to 10-min inflation of a blood-pressure cuff to 200 mm HG (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed in arm 6.
实验性的：RIPC-Group 1
Three cycles of 5- min upper limb ischemia
程序：Remote ischemic preconditioning (RIPC)
3 cycles or more cycles of 5 to 10-min inflation of a blood-pressure cuff to 200 mm HG (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed in arm 6.
实验性的：RIPC-Group 2
Three cycles of 7-min upper limb ischemia
程序：Remote ischemic preconditioning (RIPC)
3 cycles or more cycles of 5 to 10-min inflation of a blood-pressure cuff to 200 mm HG (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed in arm 6.
实验性的：RIPC-Group 3
Three cycles of 10-min upper limb ischemia
程序：Remote ischemic preconditioning (RIPC)
3 cycles or more cycles of 5 to 10-min inflation of a blood-pressure cuff to 200 mm HG (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed in arm 6.
实验性的：RIPC-Group 4
Three Cycles of 5-min upper limb ischemia. If there is no response this will be followed by 2 cycles of 10-min upper-limb ischemia
程序：Remote ischemic preconditioning (RIPC)
3 cycles or more cycles of 5 to 10-min inflation of a blood-pressure cuff to 200 mm HG (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed in arm 6.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in urinary [TIMP-2]*[IGFBP7]
大体时间：within 12 hours after CPB
Biomarkers will be measured at different time points after to evaluate the effect of RIPC on [TIMP-2]*[IGFBP7]
within 12 hours after CPB

次要结果测量

结果测量
措施说明
大体时间
AKI within 72 hours
大体时间：72 h
72 h
Dialysis within 7 days of surgery
大体时间：7 days
7 days
All-cause-mortality at 90 days
大体时间：90 d
90 d
Dialysis at day 90
大体时间：90 days
90 days
Renal recovery at day 90
大体时间：90 days
90 days
MAKE 90
大体时间：90 days
major adverse kidney events
90 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital Muenster

合作者

Else Kröner Fresenius Foundation

调查人员

  • 学习椅：Melanie Meersch、University Hospital Muenster

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年12月1日

初级完成 (预期的)

2019年6月1日

研究完成 (预期的)

2019年9月1日

研究注册日期

首次提交

2016年12月15日

首先提交符合 QC 标准的

2016年12月15日

首次发布 (估计)

2016年12月20日

研究记录更新

最后更新发布 (实际的)

2018年1月30日

上次提交的符合 QC 标准的更新

2018年1月29日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 04-AnIt-16

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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