Acute Kidney InjuryNCT03597074
Doppler Ultrasound for Prediction of Reversibility of Acute Kidney Injury in Septic ICU Patients
An observational study of Acute Kidney Injury and Sepsis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Sepsis, Renal Resistive Index
- What is being tested?
- color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularization
- How many people
- 32 participants
- Where
- 1 siteGreece
- Study dates
- 2 Mar 2017to 2 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Septic patients in ICU
- Age 18 years or older
Who cannot join
- ICU stay less than 3 days
Trial locations and contacts
1 site in 1 country.
Greece1 site
1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece
Thessaloniki, 57010
About this study
Official title: Diagnostic Value of Doppler Ultrasound for Early Prediction of Reversibility of Acute Kidney Injury in Septic ICU Patients
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.
- Conditions
- Acute Kidney Injury, Sepsis, Renal Resistive Index
- Being tested
- color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularization
- Keywords
- ICU, Renal Resistive Index, Acute Kidney Injury, Sepsis
- Medical subject headings
- Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularizationDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
RI as a prognostic factor for AKI persistence
without units (range 0 to 1)
Measured: 3 days
Secondary outcomes (2)
semi-quantitative US evaluation of renal vasculature
without units (score from 1 to 4)
Measured: 3 days
FENa (Fractional Excretion of Sodium)
% percentage
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start2 Mar 2017
- Primary completion31 Aug 2017
- Study completion2 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- George Papanicolaou Hospital
- Responsible party
- Principal investigator, Evangelos Kaimakamis, Aristotle University Of Thessaloniki
- Investigators
- Militsa Bitzani, MD, PhD, Study director, 1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597074
- Sponsor's protocol ID
- NT001
- Status last verified
- Jul 2018
- First submitted
- 27 Jun 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sheet can be shared with other researchers as soon as a publication of the results is achieved.
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 25746587Schnell 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 at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Doppler Ultrasound for Early Prediction of Reversibility of Acute Kidney Injury in Septic ICU Patients
- ClinicalTrials.gov ID
- NCT03597074
- Acronym / sponsor ID
- NT001
- Conditions
- Acute Kidney Injury, Sepsis, Renal Resistive Index
- Keywords
- ICU, Renal Resistive Index, Acute Kidney Injury, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- George Papanicolaou Hospital
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 2 Sep 2017 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularizationPatients 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 |
| 2 | – | Diagnostic Test: color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularizationPatients 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 |
| 3 | – | Diagnostic Test: color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularizationPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Septic patients in ICU
- Age 18 years or older
Key exclusion criteria (1 listed)
- ICU stay less than 3 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularizationUse 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 | 1, 2, 3 |
Primary outcome
RI as a prognostic factor for AKI persistence
Time frame: 3 days
without units (range 0 to 1)
2 secondary outcomes
semi-quantitative US evaluation of renal vasculature
Time frame: 3 days
FENa (Fractional Excretion of Sodium)
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Background: PubMed 25746587Ninet 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.
- Background: PubMed 23042202Schnell 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.
- Individual participant dataSharing planned: No. Data sheet can be shared with other researchers as soon as a publication of the results is achieved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Militsa Bitzani, MD, PhD study director
1st ICU, "G.Papanikolaou" General Hospital of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Sepsis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RI as a prognostic factor for AKI persistence (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03597074, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.