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

Completed

• Conditions: Renal Resistive Index; Acute Kidney Injury; Sepsis
• Interventions: Diagnostic Test: color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularization

• Registration Number: NCT03597074
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-03-02
• Primary Completion: 2017-08-31
• Study Completion: 2017-09-02
• Study First Submitted: 2018-06-27
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-12
• Last Update Submitted: 2018-07-12
• Study First Posted: 2018-07-24
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Septic patients in ICU
• Age 18 years or older

Exclusion Criteria

• ICU stay less than 3 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularization	Patients without AKI progression Use of color Doppler Ultrasound derived Renal Resistive Index (RI) and semi-quantitative evaluation of intra-renal vascularization for early prognosis of AKI progression
3	color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularization	Patients with Persistent AKI Use of color Doppler Ultrasound derived Renal Resistive Index (RI) and semi-quantitative evaluation of intra-renal vascularization for early prognosis of AKI progression
2	color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularization	Patients with Transient AKI 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 Outcome Measures

Name	Time	Method
RI as a prognostic factor for AKI persistence	3 days	without units (range 0 to 1)

Secondary Outcome Measures

Name	Time	Method
semi-quantitative US evaluation of renal vasculature	3 days	without units (score from 1 to 4)
FENa (Fractional Excretion of Sodium)	3 days	% percentage

Trial Locations

Locations (1)

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