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CompletedNCT03597074Updated Jul 24, 2018

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

An observational study in Acute Kidney Injury, Sepsis and Renal Resistive Index, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-24.

Sponsored by Aristotle University Of Thessaloniki · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Acute Kidney Injury
  • Sepsis
  • Renal Resistive Index

Keywords

  • ICU
  • Renal Resistive Index
  • Acute Kidney Injury
  • Sepsis
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In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 32 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects were included if they developed sepsis plus AKI during their hospitalization in the ICU, regardless of the underlying cause. The presence of Acute Kidney Injury was determined according to the KDIGO guidelines, i.e. at least stage 1 AKI. The categorization of AKI as transient or persistent was determined by the normalization of the kidney function after the administration of appropriate therapy and support in the ICU environment and after 3 days of hospitalization. All consecutive patients with sepsis were included, with the exception of those surviving less than three days, to determine whether they had AKI

Inclusion criteria

  • Septic patients in ICU
  • Age 18 years or older

Exclusion criteria

Exclusion Criteria:

  • ICU stay less than 3 days
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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

  • 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

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

  • 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

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

Interventions

  • Diagnostic testcolor 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

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What researchers measure

Primary outcomes

  1. RI as a prognostic factor for AKI persistence

    without units (range 0 to 1)

    Time frame: 3 days

Secondary outcomes

  1. semi-quantitative US evaluation of renal vasculature

    without units (score from 1 to 4)

    Time frame: 3 days

  2. FENa (Fractional Excretion of Sodium)

    % percentage

    Time frame: 3 days

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Study locations

1 site
  • 1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece
    Thessaloniki, 57010, Greece
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References and documents

Publications

  • 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. PubMed 25746587 ↗
  • 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. PubMed 23042202 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 5, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data sheet can be shared with other researchers as soon as a publication of the results is achieved.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03597074
Lead sponsor
Aristotle University Of Thessaloniki
Collaborators
George Papanicolaou Hospital
Responsible party
Evangelos Kaimakamis (Principal Investigator, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Jul 24, 2018
Start date
Mar 2, 2017
Primary completion
Aug 31, 2017
Completion
Sep 2, 2017
Last update
Jul 24, 2018

Study contacts

Militsa Bitzani, MD, PhD
study director · 1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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