Acute Kidney InjuryNCT04426032
Predictive Value of Doppler RSI for Prediction of AKI in Septic Patients in ICU
An observational study of Acute Kidney Injury and Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Acute kidney injury (AKI) Diagnosis is based on rising creatinine. Intrarenal vasoconstriction occurs earlier and measuring flow resistance in the renal circulation (Renal Resistive Index (RRI)) could become part of vital organ function assessment using Doppler ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Kidney Injury, Sepsis
- What is being tested?
- Renal Doppler Ultrasound
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 31 Jan 2021
- 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 to 60 years
- All sexes
- Adult
Study population: Patients of both sex admitted to ICU, with criteria of sepsis, and normal renal function on admission.
Who may be able to join
- Patients who have criteria of sepsis on admission which include two or more of SIRS which include: (Temperature >38°C or <36°C, Heart rate >90/min, Respiratory rate >20/min or PaCO2 <32mmHg (4.3kPa) and White blood cell count >12000/mm3 or <4000/mm3 or >10% immature bands.) in addition to suspected or confirmed infection.
- Patients who have normal renal function on admission.
Who cannot join
- Currently recovering from an AKI at the time of inclusion and Renal impairment on admission.
- Patients with obstructive renal failure, renal artery stenosis were excluded from this study.
- Patients on chemotherapy and/or radiotherapy.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of Doppler Renal Resistive Index for Prediction of Acute Kidney Injury in Septic Patients in Intensive Care Unit.
Acute kidney injury (AKI) Diagnosis is based on rising creatinine. Intrarenal vasoconstriction occurs earlier and measuring flow resistance in the renal circulation (Renal Resistive Index (RRI)) could become part of vital organ function assessment using Doppler ultrasound.
The aim of this study is to predict AKI in septic patients in ICU by measuring RRI on admission by comparing two groups of patients, first group with RRI of normal value (0.6-0.7) and the other group with high RRI more than 0.7 and both with normal renal function on admission.
Read the detailed description
Patients who have criteria of sepsis, with normal renal function on admission will undergo Renal Doppler Ultrasound examination to measure Renal resistive index.
Patients will be divided into 2 groups:
- Group (A) patients with renal resistive index between 0.6 and 0.7 (normal RRI).
- Group (B) patients with renal resistive index more than 0.7 (high RRI).
- Conditions
- Acute Kidney Injury, Sepsis
- Being tested
- Renal Doppler Ultrasound
- Keywords
- 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.
Renal Doppler UltrasoundDiagnostic test
Measurement of Renal resistive index
| Study group | Role | What they receive |
|---|---|---|
| Patients with RRI between 0.6 and 0.7 | Normal renal resistive index Receives: Diagnostic Test: Renal Doppler Ultrasound | |
| Patients with RRI more than 0.7 | High renal resistive index Receives: Diagnostic Test: Renal Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of AKI
incidence of AKI related to Renal resistive index.
Measured: 1 day at admission
Secondary outcomes (3)
APACHE III score
Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 299 worse)
Measured: 1 day at admission
APACHE IV score
Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 286 worse)
Measured: 1 day at admission
SOFA score
Sequential Organ Failure Assessment (SOFA) score. Score Range (0 better - 24 worse)
Measured: 1 day at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jul 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Saleh Ahmed Massoud, Ain Shams University
- Investigators
- Mohamed Saleh Ahmed, MD, Study director, Lecturer of Anesthesia and Intensive CareMohammed Saeed Abdelaziz, MD, Study chair, Professor of Anesthesia and Intensive CareMona Refaat Hosney, MD, Study director, Assistant Professor of Anesthesia and Intensive CareAhmed Abdelsattar Abuelmajd, MBBCH, Principal investigator, Candidate of master degree in general intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426032
- Sponsor's protocol ID
- FMASU M S 299 / 2020
- Status last verified
- Jul 2021
- First submitted
- 9 Jun 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Doppler Renal Resistive Index for Prediction of Acute Kidney Injury in Septic Patients in Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT04426032
- Acronym / sponsor ID
- FMASU M S 299 / 2020
- Conditions
- Acute Kidney Injury, Sepsis
- Keywords
- Acute Kidney Injury, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 11 Jun 2020 (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.
Acute kidney injury (AKI) Diagnosis is based on rising creatinine. Intrarenal vasoconstriction occurs earlier and measuring flow resistance in the renal circulation (Renal Resistive Index (RRI)) could become part of vital organ function assessment using Doppler ultrasound.
The aim of this study is to predict AKI in septic patients in ICU by measuring RRI on admission by comparing two groups of patients, first group with RRI of normal value (0.6-0.7) and the other group with high RRI more than 0.7 and both with normal renal function on admission.
Detailed description
Patients who have criteria of sepsis, with normal renal function on admission will undergo Renal Doppler Ultrasound examination to measure Renal resistive index.
Patients will be divided into 2 groups:
- Group (A) patients with renal resistive index between 0.6 and 0.7 (normal RRI).
- Group (B) patients with renal resistive index more than 0.7 (high RRI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with RRI between 0.6 and 0.7 | – | Diagnostic Test: Renal Doppler UltrasoundNormal renal resistive index |
| Patients with RRI more than 0.7 | – | Diagnostic Test: Renal Doppler UltrasoundHigh renal resistive index |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients of both sex admitted to ICU, with criteria of sepsis, and normal renal function on admission.
Key inclusion criteria (2 listed)
- Patients who have criteria of sepsis on admission which include two or more of SIRS which include: (Temperature >38°C or <36°C, Heart rate >90/min, Respiratory rate >20/min or PaCO2 <32mmHg (4.3kPa) and White blood cell count >12000/mm3 or <4000/mm3 or >10% immature bands.) in addition to suspected or confirmed infection.
- Patients who have normal renal function on admission.
Key exclusion criteria (4 listed)
- Currently recovering from an AKI at the time of inclusion and Renal impairment on admission.
- Patients with obstructive renal failure, renal artery stenosis were excluded from this study.
- Patients on chemotherapy and/or radiotherapy.
- Pregnancy.
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 |
|---|---|---|
| Renal Doppler UltrasoundMeasurement of Renal resistive index | Diagnostic test | Patients with RRI between 0.6 and 0.7, Patients with RRI more than 0.7 |
Primary outcome
incidence of AKI
Time frame: 1 day at admission
incidence of AKI related to Renal resistive index.
3 secondary outcomes
APACHE III score
Time frame: 1 day at admission
APACHE IV score
Time frame: 1 day at admission
SOFA score
Time frame: 1 day at admission
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 20 Jul 2021.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
Related trials for Acute Kidney Injury
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Mohamed Saleh Ahmed, MD study director
Lecturer of Anesthesia and Intensive Care
Mohammed Saeed Abdelaziz, MD study chair
Professor of Anesthesia and Intensive Care
Mona Refaat Hosney, MD study director
Assistant Professor of Anesthesia and Intensive Care
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 Ain Shams University at 1 site in Egypt.
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 4 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 20 Jul 2021. 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 Egypt. 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?
incidence of AKI (time frame: 1 day at admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2021.