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

NCT03509935 | Completed

• 1 other identifier: US to guide ressuscitation
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Kidney Injury

Keywords

ultrasound,; high-risk surgery; intensive care

Outcome Measures

Primary Outcomes (1)

• Acute renal failure (ARF)

  Creatinine elevation or oliguria according to KDIGO classification Impact in the incidence of ARF in major surgeries

  One week

Secondary Outcomes (8)

• Volume replacement within the first 36 hours.

  36 hours

• Use of vasopressor drugs.

  36 hours

• Use of inotropic drugs.

  36hours

• Length of invasive mechanical ventilation

  36 hours

• Length of ICU stay

  28 days

Study Arms (2)

Intervention Ultrasound Group

EXPERIMENTAL

Patients will be submitted to Ultrasound protocol, namely: 1. In the first 6 to 12 hours of admission to ICU 2. Second US after 12-24 hours of inclusion. 3. 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

Control Group

NO INTERVENTION

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.

Interventions

Intervention Ultrasound Group OTHER

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.

Intervention Ultrasound Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Hospital das Clínicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Vandack Nobre, PhD

  Hospital das Clincias UFMG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 27, 2018
• Study Start: March 12, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: July 22, 2020

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)