Use of Bedside Ultrasonography on the Incidence of Acute Renal Failure in High-risk Surgical Patients: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Acute renal failure (ARF)
研究概览
简要总结
The mortality and postoperative complications of high risk surgeries vary in the different series. The management of this group of patients in intensive care unit (ICU) is fundamental to improve these outcomes. The objective of this study will be to evaluate whether the use of bedside ultrasound has an impact on the management of this group of patients with a consequent reduction in the incidence of acute renal failure in ICU and, secondarily, the incidence of associated complications. All adult patients (≥ 18 years old) admitted to ICU at Hospital das Clinicas of UFMG in the immediate postoperative period of major surgery with indication of ICU monitoring will be included and randomly randomized to the control or intervention group. The control group will be conducted by the intensive care physicians in charge without the US, while the second group will be conducted based in US findings. The US protocol will consist of a pulmonary US in four windows in each hemithorax , qualitative assessment of contractility and variation of inferior vena cava diameter. The primary outcome will be the development of acute renal failure as measured by the KDIGO score. Secondary outcomes will be length of ICU and hospital stay, ICU and 28 days mortality, length spent in mechanical ventilation, accumulated water balance, noradrenaline and dobutamine dose. Serum and urinary biomarkers will also be evaluated. Key words: ultrasound, high-risk surgery, intensive care
详细描述
This is a single-center randomized clinical trial to be performed at the Adult Intensive Care Unit (ICU) of the Clinical Hospital of the Federal University of Minas Gerais, Belo Horizonte. The ICU is a clinical-surgical unit that has 18 beds with admission of approximately 100 patients per month, being 70% surgical patients and 30% clinical patients. Postoperative patients who meet the inclusion criteria reported below will be randomized to guide therapy according to ultrasound findings at the bedside versus a group that will not perform this method. Serum and urine samples will be collected in three times: admission (T0), after 12 hours (T1) and after 24 hours (T2) to analysed urine and serum biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Age equal or superior to 18 years.
- •Major surgeries requiring ICU admission associated with one of the following criteria:
- •Use of vasoactive drugs
- •Use of inotropic drugs
- •Mean blood pressure less than 65 mmHg or SBP <90 mmHg.
- •Hyperlactatemia> 2 mmol / L
- •Heart rate> 90 bpm.
- •Invasive mechanical ventilation required for at least 6 hours at the time of inclusion.
- •Hypoxia: satO2 <92% in ambient air.
- •Length of surgery greater than 4 hours.
- •Request for transfusion of blood products in a surgical block
- •Oliguria during procedure, defined as diuresis <0.5 ml/kg/h.
排除标准
- •Patients who do not agree to the terms of the
- •Dying patients with impending death in the first 24 hours
- •Patients in a previous renal replacement therapy program
结局指标
主要结局
Acute renal failure (ARF)
时间窗: One week
Creatinine elevation or oliguria according to KDIGO classification Impact in the incidence of ARF in major surgeries
次要结局
- Length of invasive mechanical ventilation(36 hours)
- Length of Hospital stay(28 days)
- Use of vasopressor drugs.(36 hours)
- Length of ICU stay(28 days)
- 28 days mortality(28 days)
- Volume replacement within the first 36 hours.(36 hours)
- Use of inotropic drugs.(36hours)
- Mortality in ICU(28 days)
研究者
Vandack Alencar Nobre
Principal Investigator
Federal University of Minas Gerais