KIDNEY - LUNG INTERACTION: the Effect of End-expiratory Pressure on Renal Perfusion. Non-invasive Evaluation.
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
Silvia De Rosa
Medical Doctor
St. Bortolo Hospital
