Renal Resistive IndexNCT06009445
Renal Resistive Index as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis
An observational study of Renal Resistive Index and Acute Kidney Injury, run by Tanta University at 1 site in Egypt.
Trial summary
We aim from this study to investigate the role of renal resistance index (RRI) in evaluation of Acute kidney injury development and fluid administration in sepsis patients considering the change in RRI values over 7 days from admission as a predictor of AKI development Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Renal Resistive Index, Acute Kidney Injury, Sepsis
- What is being tested?
- Renal resistive index
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jul 2024
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Tanta university surgical intensive care unit (SICU)
Who may be able to join
- Age over 21 years
- meet Sepsis 3 criteria (potential source of infection , host response and organ dysfunction) but not in septic shock.
Who cannot join
- patients during pregnancy.
- patients with hepatorenal syndrome.
- Poor abdominal echogenicity eg.(morbid obesity ,increase intra abdominal pressure )
- Severe acute or chronic renal insufficiency .
- Dialysis dependency.
- Renal transplantation.
- Known renal artery stenosis.
- Mono-kidney, kidney tumor, anatomic kidney abnormalities.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Elgharbia, 31527
Safinaz A Aboelfetoh, MBBCh, 00201148855752, noralamar34@gmail.com
Ahmed M Hamed, MD
About this study
Official title: Renal Resistive Index by Renal Doppler Ultrasound as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis Patients: Cohort Study
We aim from this study to investigate the role of renal resistance index (RRI) in evaluation of Acute kidney injury development and fluid administration in sepsis patients considering the change in RRI values over 7 days from admission as a predictor of AKI development
Read the detailed description
Acute kidney injury (AKI) is one of the most common problems in critically ill patients in the clinic. AKI can be caused by various factors, such as hypovolemia, shock, major surgery, trauma, and heart failure, of which sepsis is the most common
- Conditions
- Renal Resistive Index, Acute Kidney Injury, Sepsis
- Being tested
- Renal resistive index
- 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 resistive indexDiagnostic test
Also called Renal Doppler Ultrasound
The calculation formula for Renal resistive index (RRI) as follows :
(systolic peak flow velocity _ diastolic minimum flow velocity )/systolic peak flow velocity .
will be measured with ultrasound-Doppler using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney.
The median value of each section will be used and the 3 median values of each kidney will be averaged.
| Study group | Role | What they receive |
|---|---|---|
| AKI group | Acute kidney injury (AKI) was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria.
The KDIGO guidelines define AKI as follows:
* Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or
* Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or
* Urine volume <0.5 mL/kg/hour for six hours Receives: Diagnostic Test: Renal resistive index | |
| Non AKI group | Patients who will no develop Acute kidney injury (AKI). Receives: Diagnostic Test: Renal resistive index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of AKI development by renal resistance index (RRI)
AKI was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria.
The KDIGO guidelines define AKI as follows
- Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or
- Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or
- Urine volume <0.5 mL/kg/hour for six hours
Measured: 7 days from admission
Secondary outcomes (4)
Evaluation of fluid administration
RRI and other hypoperfusion markers after fluid challenge and divided into responder to fluid (Time 1 F) and non responder with noradrenaline administration (Time 1 N) .
Measured: 7 days from admission
Length of ICU stay
Length of ICU stay till discharge will be measured.
Measured: 2 months from admission till discharge
cumulative fluid balance over 7 days
Cumulative fluid balance over 7 days and urine output (intake -output) will be measured.
Measured: 7 days from admission
The incidence of 28 day mortality
The incidence of mortality will be measured at 28 day.
Measured: 28 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Resistive IndexStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safinaz Abdelkhalek Aboelfetoh, Tanta University
- Investigators
- Safinaz A Aboelfetoh, MBBCh, Principal investigator, Anesthesiology, Faculty of Medicine, Tanta University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009445
- Sponsor's protocol ID
- 36264MS189/5/23
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Resistive Index by Renal Doppler Ultrasound as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis Patients: Cohort Study
- ClinicalTrials.gov ID
- NCT06009445
- Acronym / sponsor ID
- 36264MS189/5/23
- Conditions
- Renal Resistive Index, Acute Kidney Injury, Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 24 Aug 2023 (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.
We aim from this study to investigate the role of renal resistance index (RRI) in evaluation of Acute kidney injury development and fluid administration in sepsis patients considering the change in RRI values over 7 days from admission as a predictor of AKI development
Detailed description
Acute kidney injury (AKI) is one of the most common problems in critically ill patients in the clinic. AKI can be caused by various factors, such as hypovolemia, shock, major surgery, trauma, and heart failure, of which sepsis is the most common
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI group | – | Diagnostic Test: Renal resistive indexAcute kidney injury (AKI) was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria. The KDIGO guidelines define AKI as follows: * Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or * Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or * Urine volume <0.5 mL/kg/hour for six hours |
| Non AKI group | – | Diagnostic Test: Renal resistive indexPatients who will no develop Acute kidney injury (AKI). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Tanta university surgical intensive care unit (SICU)
Key inclusion criteria (2 listed)
- Age over 21 years
- meet Sepsis 3 criteria (potential source of infection , host response and organ dysfunction) but not in septic shock.
Key exclusion criteria (8 listed)
- patients during pregnancy.
- patients with hepatorenal syndrome.
- Poor abdominal echogenicity eg.(morbid obesity ,increase intra abdominal pressure )
- Severe acute or chronic renal insufficiency .
- Dialysis dependency.
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 resistive indexAlso: Renal Doppler UltrasoundThe calculation formula for Renal resistive index (RRI) as follows : (systolic peak flow velocity _ diastolic minimum flow velocity )/systolic peak flow velocity . will be measured with ultrasound-Doppler using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney. The median value of each section will be used and the 3 median values of each kidney will be averaged. | Diagnostic test | AKI group, Non AKI group |
Primary outcome
Prediction of AKI development by renal resistance index (RRI)
Time frame: 7 days from admission
AKI was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria. The KDIGO guidelines define AKI as follows * Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or * Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or * Urine volume <0.5 mL/kg/hour for six hours
4 secondary outcomes
Evaluation of fluid administration
Time frame: 7 days from admission
Length of ICU stay
Time frame: 2 months from admission till discharge
cumulative fluid balance over 7 days
Time frame: 7 days from admission
The incidence of 28 day mortality
Time frame: 28 days from admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Role of Renal Duplex Resistive Index (RRI) and Pulsatility Index (PI) in Assessment of Early Renal Microvascular Changes in Diabetic Patient
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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.
Safinaz A Aboelfetoh, MBBCh principal investigator
Anesthesiology, Faculty of Medicine, Tanta University, Egypt.
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 Renal Resistive Index and Acute Kidney Injury, run by Tanta 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 8 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: status not confirmed, as of the sponsor's last update on 24 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safinaz A Aboelfetoh, MBBCh (00201148855752, noralamar34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of AKI development by renal resistance index (RRI) (time frame: 7 days from 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 24 Aug 2023.