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

NCT03597074 | Completed

• 1 other identifier: NT001
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Sepsis; Renal Resistive Index

Keywords

ICU; Renal Resistive Index; Acute Kidney Injury; Sepsis

Outcome Measures

Primary Outcomes (1)

• RI as a prognostic factor for AKI persistence

  without units (range 0 to 1)

  3 days

Secondary Outcomes (2)

• semi-quantitative US evaluation of renal vasculature

  3 days

• FENa (Fractional Excretion of Sodium)

  3 days

Study Arms (3)

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

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Septic patients in ICU
• Age 18 years or older

You may not qualify if:

• ICU stay less than 3 days

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• George Papanicolaou Hospital: collaborator

Study Sites (1)

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

Thessaloniki, 57010, Greece

Location

Related 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.

  PMID: 25746587 BACKGROUND

• 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.

  PMID: 23042202 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Militsa Bitzani, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 24, 2018
• Study Start: March 2, 2017
• Primary Completion: August 31, 2017
• Study Completion: September 2, 2017
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)