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

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

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Intervention Ultrasound Group

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Hospital das Clínicas - Universidade Federal de Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Ultrasound Group; Patients will be submitted to Ultrasound protocol, namely: In the first 6 to 12 hours of admission to ICU; Second US after 12-24 hours of inclusion.; Third US after 24-48 hours of inclusion. Protocol: US 4 pulmonary quadrants in each hemithorax: anterior and lateral, upper and lower regions.; US inferior vena cava, collapsability or distensibility index according to the patient's conditions, in spontaneous or controlled ventilation, respectively.; Cardiac US: subjective evaluation of contractility between normal, reduced or severely reduced. The US findings will be communicated to the attending physicians who will conduct the patient, according to the protocol, recommending the administration of volume or not, and the use of vasopressors and/or inotropic drugs.	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.
No Intervention: Control Group; Patients randomized to this group will receive care according to the indication of the attending physicians, composed mainly of intensive care physicians, without bedside US. Patients may be submitted to echocardiographic, abdominal and vascular examinations, among others, requested to ultrasound service, according to the indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute renal failure (ARF)	Creatinine elevation or oliguria according to KDIGO classification Impact in the incidence of ARF in major surgeries	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume replacement within the first 36 hours.	Quantity of volume administered during first 36 hours of admission in ICU	36 hours
Use of vasopressor drugs.	vasopressor drugs requirement mcg/kg/min	36 hours
Use of inotropic drugs.	Inotropic drug requirement in mcg/kg/min	36hours
Length of invasive mechanical ventilation	Days spent in invasive mechanical ventilation	36 hours
Length of ICU stay	Days spent in ICU	28 days
Length of Hospital stay	Days spent in Hospital	28 days
Mortality in ICU	Any cause of mortality during ICU stay	28 days
28 days mortality	Any cause of mortality in 28 days	28 days

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Vandack Nobre, PhD, Hospital das Clincias UFMG

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: intensive care; high-risk surgery; ultrasound,
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: US to guide ressuscitation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No