跳至主要内容
临床试验/NCT03747731
NCT03747731Unknown不适用

KIDNEY - LUNG INTERACTION: the Effect of End-expiratory Pressure on Renal Perfusion. Non-invasive Evaluation.

St. Bortolo Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2018年11月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
109
试验地点
1
主要终点
Association between IR and PEEP

研究概览

简要总结

The present study aims to evaluate, with non-invasive methods, the relationships existing between PEEP and renal perfusion in patients undergoing surgery and requiring ventilatory support and monitoring in intensive care. Renal perfusion will be assessed at baseline (PEEP 0), subsequently ,at the application of progressive increases of PEEP. At the end of the measurements, the implications of the use of PEEP on the renal vascular system will be analyzed.

详细描述

The present physiological, monocentric, observational clinical study evaluates the effect of progressive PEEP increases on renal perfusion in mechanically ventilated patients who underwent surgery with the need of ventilatory support and monitoring in intensive care.

Precisely, will be evaluated:

  • The morphometric parameters (coronal diameter and cortico-medullary thickness) and the renal resistive indices (IR). The inter-lobar arteries will be sampled and the IRs will be measured as the upper and lower level and the mesorenes. Measurements will be performed both in the kidney and in baseline conditions and incremental values of PEEP (0 - 6 - 12).
  • Gas exchanges, FC, systolic BP, diastolic and mean, Pmax, P1 and P2 of the airways, total and ohmic resistances and static respiratory compliance indexed for weight body (RRSmaxI, RRSminI, CrsI will be recorded).

The intra-class correlation coefficient will be measured to estimate the intra-observer reproducibility of the conducted measurement.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • •18 Years and older
  • •Receiving mechanical ventilation, invasive blood pressure monitoring and an urinary catheter to monitor diuresis
  • •Need for postoperative monitoring in intensive care
  • •Written informed consent;

排除标准

  • •Acute kidney injury defined according to KDIGO guidelines;
  • •Pre-existing chronic renal disease;
  • •Heart failure;
  • •Sepsis and Septic Shock;
  • •Hemodynamic instability with the need for vasoactive support;
  • •Chronic or occasional therapy with drugs that could modify the renal blood flow and that can not be suspended two days before the study (Vasoactive agents, Ace-inhibitors, Beta-blockers, NSAIDs, Sartans and Diuretics therapy);
  • •Presumed or established state of pregnancy;
  • •Refusal of informed consent;

结局指标

主要结局

Association between IR and PEEP

时间窗: Change from baseline to 60 minutes

Resistive index will be measured in both kidney and recorded using multifrequency convex probe.The association between positive end expiratory pressure and resistive index will be analyzed as the primary outcome.

次要结局

  • Association between PEEP and Hemodynamics Paramenters(Change from baseline to 60 minutes)

研究者

发起方
St. Bortolo Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia De Rosa

Medical Doctor

St. Bortolo Hospital

研究点 (1)

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A Non-invasive Evaluation of Kidney-Lung Interactions | 临床试验