Clinical trial NCT03597074: Doppler Ultrasound for Prediction of Reversibility of Acute Kidney Injury in Septic ICU Patients
Official title: Diagnostic Value of Doppler Ultrasound for Early Prediction of Reversibility of Acute Kidney Injury in Septic ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Sepsis
Renal Resistive Index
Keywords: ICU
Renal Resistive Index
Acute Kidney Injury
Sepsis
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: George Papanicolaou Hospital
First posted: 2018-07-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* Septic patients in ICU
* Age 18 years or older

Exclusion Criteria:

* ICU stay less than 3 days

Primary outcomes:
measure: RI as a prognostic factor for AKI persistence
timeFrame: 3 days
Secondary outcomes:
measure: semi-quantitative US evaluation of renal vasculature
timeFrame: 3 days
measure: FENa (Fractional Excretion of Sodium)
timeFrame: 3 days
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: 1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece
Study officials:
affiliation: 1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece
name: Militsa Bitzani, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.