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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03509935
Enrollment
111
Registered
2018-04-27
Start date
2018-03-12
Completion date
2019-03-31
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

ultrasound,, high-risk surgery, intensive care

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.

Interventions

OTHERIntervention 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.

Sponsors

Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Use of vasopressor drugs.36 hoursvasopressor drugs requirement mcg/kg/min
Use of inotropic drugs.36hoursInotropic drug requirement in mcg/kg/min
Length of invasive mechanical ventilation36 hoursDays spent in invasive mechanical ventilation
Volume replacement within the first 36 hours.36 hoursQuantity of volume administered during first 36 hours of admission in ICU
Length of Hospital stay28 daysDays spent in Hospital
Mortality in ICU28 daysAny cause of mortality during ICU stay
28 days mortality28 daysAny cause of mortality in 28 days
Length of ICU stay28 daysDays spent in ICU

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026