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NCT Number: NCT03597074

Doppler Ultrasound for Prediction of Reversibility of Acute Kidney Injury in Septic ICU Patients

Purpose: The aim of this study was to assess the ability of early discrimination between transient and persistent Acute Kidney Injury (AKI) using the color Doppler Ultrasound derived Renal Resistive Index (RI) and semi-quantitative evaluation of intra-renal vascularization in septic patients in an Intensive Care Unit (ICU).

Methods: Prospective observational cohort study with unselected, with 32 adult consecutive septic patients. Patients were divided into 3 groups: Group 1: patients without progression to AKI, Group 2: transient AKI, Group 3: persistent AKI.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Resistive Index Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece

Thessaloniki, 57010, Greece

About this study

Purpose: The aim of this study was to assess the ability of early discrimination between transient and persistent AKI using the color Doppler Ultrasound derived Renal Resistive Index (RI) and semi-quantitative evaluation of intra-renal vascularization in septic patients in an Intensive Care Unit (ICU). Additionally, the investigators aimed to identify whether these indexes are early predictors of the prognosis of renal function in this group of patients. And compare the diagnostic accuracy of those and other renal indexes for the identification of AKI reversibility.

Methods: This was a prospective observational cohort study with unselected, consecutive septic patients included. Thirty-two adult septic patients hospitalized in a general ICU were studied. After the determination of sepsis, patients were divided into 3 groups: Group 1 included patients without progression to AKI, Group 2 included patients with transient AKI and Group 3 patients with persistent AKI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Septic patients in ICU
  • Age 18 years or older

Exclusion criteria

  • ICU stay less than 3 days

Treatment and study plan

color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularization

Diagnostic Test

Use of color Doppler Ultrasound derived Renal Resistive Index (RI) and semi-quantitative evaluation of intra-renal vascularization for early prognosis of AKI progression

Primary outcomes

  1. RI as a prognostic factor for AKI persistence

    Time frame: 3 days

    without units (range 0 to 1)

Secondary outcomes

  1. semi-quantitative US evaluation of renal vasculature

    Time frame: 3 days

    without units (score from 1 to 4)

  2. FENa (Fractional Excretion of Sodium)

    Time frame: 3 days

    % percentage

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • George Papanicolaou Hospital

Registry information

Official study title

Diagnostic Value of Doppler Ultrasound for Early Prediction of Reversibility of Acute Kidney Injury in Septic ICU Patients

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2018
Registry last updated
Jul 24, 2018

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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