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NCT Number: NCT03509935

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Acute renal failure (ARF)

    Time frame: One week

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

Secondary outcomes

  1. Volume replacement within the first 36 hours.

    Time frame: 36 hours

    Quantity of volume administered during first 36 hours of admission in ICU

  2. Use of vasopressor drugs.

    Time frame: 36 hours

    vasopressor drugs requirement mcg/kg/min

  3. Use of inotropic drugs.

    Time frame: 36hours

    Inotropic drug requirement in mcg/kg/min

  4. Length of invasive mechanical ventilation

    Time frame: 36 hours

    Days spent in invasive mechanical ventilation

  5. Length of ICU stay

    Time frame: 28 days

    Days spent in ICU

  6. Length of Hospital stay

    Time frame: 28 days

    Days spent in Hospital

  7. Mortality in ICU

    Time frame: 28 days

    Any cause of mortality during ICU stay

  8. 28 days mortality

    Time frame: 28 days

    Any cause of mortality in 28 days

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2018
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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