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

NCT ID: NCT03597074

Last Updated: 2018-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-02

Study Completion Date

2017-09-02

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury Sepsis Renal Resistive Index

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

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

Intervention Type 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

2

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

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

Intervention Type 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

3

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

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

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Septic patients in ICU
* Age 18 years or older

Exclusion Criteria

* ICU stay less than 3 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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George Papanicolaou Hospital

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Evangelos Kaimakamis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Militsa Bitzani, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 25746587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23042202 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NT001

Identifier Type: -

Identifier Source: org_study_id

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