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NCT03597074 Clinical Trial

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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03597074
Other study ID # NT001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2, 2017
Est. completion date September 2, 2017

Study information
Verified date July 2018
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date September 2, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Septic patients in ICU

- Age 18 years or older

Exclusion Criteria:

- ICU stay less than 3 days

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Greece 1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece Thessaloniki

Sponsors (2)
Lead Sponsor Collaborator
Aristotle University Of Thessaloniki G. Papanikolaou General Hospital of Thessaloniki, Greece

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Ninet S, Schnell D, Dewitte A, Zeni F, Meziani F, Darmon M. Doppler-based renal resistive index for prediction of renal dysfunction reversibility: A systematic review and meta-analysis. J Crit Care. 2015 Jun;30(3):629-35. doi: 10.1016/j.jcrc.2015.02.008. Epub 2015 Feb 24. Review. — View Citation

Schnell D, Deruddre S, Harrois A, Pottecher J, Cosson C, Adoui N, Benhamou D, Vicaut E, Azoulay E, Duranteau J. Renal resistive index better predicts the occurrence of acute kidney injury than cystatin C. Shock. 2012 Dec;38(6):592-7. doi: 10.1097/SHK.0b013e318271a39c. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary RI as a prognostic factor for AKI persistence without units (range 0 to 1) 3 days
Secondary semi-quantitative US evaluation of renal vasculature without units (score from 1 to 4) 3 days
Secondary FENa (Fractional Excretion of Sodium) % percentage 3 days
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