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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention Ultrasound Group
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring ultrasound,, high-risk surgery, intensive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas - Universidade Federal de Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Ultrasound Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Acute renal failure (ARF)
Creatinine elevation or oliguria according to KDIGO classification Impact in the incidence of ARF in major surgeries

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2018
Last Updated
July 20, 2020
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT03509935
Brief Title
Use of Bedside Ultrasonography on the Incidence of Acute Renal Failure in High-risk Surgical Patients
Official Title
Use of Bedside Ultrasonography on the Incidence of Acute Renal Failure in High-risk Surgical Patients: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
ultrasound,, high-risk surgery, intensive care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Ultrasound Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention Ultrasound Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute renal failure (ARF)
Description
Creatinine elevation or oliguria according to KDIGO classification Impact in the incidence of ARF in major surgeries
Time Frame
One week
Secondary Outcome Measure Information:
Title
Volume replacement within the first 36 hours.
Description
Quantity of volume administered during first 36 hours of admission in ICU
Time Frame
36 hours
Title
Use of vasopressor drugs.
Description
vasopressor drugs requirement mcg/kg/min
Time Frame
36 hours
Title
Use of inotropic drugs.
Description
Inotropic drug requirement in mcg/kg/min
Time Frame
36hours
Title
Length of invasive mechanical ventilation
Description
Days spent in invasive mechanical ventilation
Time Frame
36 hours
Title
Length of ICU stay
Description
Days spent in ICU
Time Frame
28 days
Title
Length of Hospital stay
Description
Days spent in Hospital
Time Frame
28 days
Title
Mortality in ICU
Description
Any cause of mortality during ICU stay
Time Frame
28 days
Title
28 days mortality
Description
Any cause of mortality in 28 days
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vandack Nobre, PhD
Organizational Affiliation
Hospital das Clincias UFMG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas - Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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