NCT03509935

Use of Bedside Ultrasonography on the Incidence of Acute Renal Failure in High-risk Surgical Patients

Use of Bedside Ultrasonography on the Incidence of Acute Renal Failure in High-risk Surgical Patients: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
OTHER	Intervention Ultrasound Group	Protocol: * US 4 pulmonary quadrants in each hemithorax: anterior and lateral, upper and lower regions (figure 1) * US inferior vena cava, collaborative index or distensibility according to the patient's conditions, in spontaneous or controlled ventilation, respectively. * Cardiac US: subjective evaluation of contractility in normal, discreetly reduced or severely reduced.

Timeline

• Start date: 2018-03-12
• Primary completion: 2019-03-31
• Completion: 2019-03-31
• First posted: 2018-04-27
• Last updated: 2020-07-22

Locations

1 site across 1 country: Brazil