Doppler-Based Renal UltrasoundNCT07037485
The Predictive Value of Doppler Based Renal Ultrasound and Urinary Oxygen Tension for Prediction of Acute Kidney Injury After Open Heart Surgery
An observational study of Doppler-Based Renal Ultrasound and Urinary Oxygen Tension, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to investigate the predictive value of Doppler-based renal ultrasound and urinary oxygen tension in the development of acute kidney injury after cardiac surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Doppler-Based Renal Ultrasound, Urinary Oxygen Tension, Acute Kidney Injury
- What is being tested?
- Renal resistive index, Renal Artery Pulsatility Index and Urinary oxygen tension (PUO2)
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This prospective cohort observational study will be conducted at Tanta University Hospitals for a period of at least two years, from October 2024 to September 2026, pending approval from the institutional ethics committee.
Who may be able to join
- Age above 21 years.
- Both sexes.
- Undergoing elective on-pump cardiac surgery.
Who cannot join
- Patients with chronic kidney disease.
- Patients with any renal pathology or anatomic kidney abnormalities.
- Patients on renal replacement therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Amany M Badr, Master, 00201018038038, amany.badr@med.tanta.edu.eg
Ayman A Yousef, MD
About this study
This study aims to investigate the predictive value of Doppler-based renal ultrasound and urinary oxygen tension in the development of acute kidney injury after cardiac surgery.
Read the detailed description
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a complication following cardiac surgery occurring in 15-30% of patients. It is associated with increased morbidity and mortality as well as prolonged hospital stay and higher medical costs.
The renal artery pulsatility index (RAPI), which is determined using Doppler measurements, has been reported to detect patients with a high risk of AKI. Additionally, the renal resistance index (RRI), measured by Doppler ultrasound, can accurately predict the occurrence of AKI.
Urinary oxygen partial pressure in the bladder has been shown to decrease in the setting of sepsis, reduced renal blood flow, and decreased cardiac output.
- Conditions
- Doppler-Based Renal Ultrasound, Urinary Oxygen Tension, Acute Kidney Injury, Open Heart Surgery
- Being tested
- Renal resistive index, Renal Artery Pulsatility Index, Urinary oxygen tension (PUO2)
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal resistive indexOther
It 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 inter-lobar artery will be localized, and three successive Doppler measurements at different positions in the kidney (high, middle, and low) will be performed. The average value for each kidney will be taken.
The renal resistive index will be calculated as follows:
(systolic peak flow velocity - diastolic minimum flow velocity)/systolic peak flow velocity
Renal Artery Pulsatility IndexOther
It will be measured using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care). After visualizing the kidney, the interlobular artery will be located using color Doppler mode, and the velocity of the interlobular arteries will be assessed in one or two kidneys.
The Renal Artery Pulsatility Index (RAPI) will be calculated as follows:
RAPI = [(peak systolic velocity) - (end diastolic velocity)] /average velocity
Urinary oxygen tension (PUO2)Other
Urinary oxygen tension (PUO2) will be measured preoperatively (baseline), postoperatively just after intensive care unit admission, 12 hours after surgery, and then once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients undergoing elective on-pump cardiac surgery Receives: Other: Renal resistive index; Other: Renal Artery Pulsatility Index; Other: Urinary oxygen tension (PUO2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases developed acute kidney injury
Number of cases developed acute kidney injury as defined by KIDGO guidelines (serum creatinine ≥ 0.3 mg/dL from base line within 48 hours, or ≥1.5 fold within 7 days, or urine output <0.5 mL/kg/hour for six hours) in patients undergoing open heart surgery.
Measured: 7 days after the procedure
Secondary outcomes (5)
Length of intensive care unit stay
The length of stay in an Intensive Care Unit (ICU) is defined as the duration a patient spends in the ICU, typically measured from the time of admission to the ICU until the time of discharge.
Measured: 7 days after the procedure
Length of hospital stay
Length of hospital stay will be measured from admission till discharge from hospital.
Measured: 7 days after the procedure
Need for renal replacement therapy
Need for renal replacement therapy will be recorded.
Measured: 7 days after the procedure
Number of patients developed chronic kidney disease
Number of patients developed chronic kidney disease will be recorded.
Measured: 7 days after the procedure
Mortality rate
Mortality rate will be recorded.
Measured: 7 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Oct 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Doppler-Based Renal UltrasoundStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mohamed Badr Ali Badr, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037485
- Sponsor's protocol ID
- 36265MD279/9/24
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Doppler Based Renal Ultrasound and Urinary Oxygen Tension for Prediction of Acute Kidney Injury After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT07037485
- Acronym / sponsor ID
- 36265MD279/9/24
- Conditions
- Doppler-Based Renal Ultrasound, Urinary Oxygen Tension, Acute Kidney Injury, Open Heart Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Jun 2025 (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.
This study aims to investigate the predictive value of Doppler-based renal ultrasound and urinary oxygen tension in the development of acute kidney injury after cardiac surgery.
Detailed description
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a complication following cardiac surgery occurring in 15-30% of patients. It is associated with increased morbidity and mortality as well as prolonged hospital stay and higher medical costs.
The renal artery pulsatility index (RAPI), which is determined using Doppler measurements, has been reported to detect patients with a high risk of AKI. Additionally, the renal resistance index (RRI), measured by Doppler ultrasound, can accurately predict the occurrence of AKI.
Urinary oxygen partial pressure in the bladder has been shown to decrease in the setting of sepsis, reduced renal blood flow, and decreased cardiac output.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Renal resistive index, Other: Renal Artery Pulsatility Index, Other: Urinary oxygen tension (PUO2)Patients undergoing elective on-pump cardiac surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective cohort observational study will be conducted at Tanta University Hospitals for a period of at least two years, from October 2024 to September 2026, pending approval from the institutional ethics committee.
Key inclusion criteria (3 listed)
- Age above 21 years.
- Both sexes.
- Undergoing elective on-pump cardiac surgery.
Key exclusion criteria (3 listed)
- Patients with chronic kidney disease.
- Patients with any renal pathology or anatomic kidney abnormalities.
- Patients on renal replacement therapy.
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 indexIt 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 inter-lobar artery will be localized, and three successive Doppler measurements at different positions in the kidney (high, middle, and low) will be performed. The average value for each kidney will be taken. The renal resistive index will be calculated as follows: (systolic peak flow velocity - diastolic minimum flow velocity)/systolic peak flow velocity | Other | Study group |
| Renal Artery Pulsatility IndexIt will be measured using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care). After visualizing the kidney, the interlobular artery will be located using color Doppler mode, and the velocity of the interlobular arteries will be assessed in one or two kidneys. The Renal Artery Pulsatility Index (RAPI) will be calculated as follows: RAPI = [(peak systolic velocity) - (end diastolic velocity)] /average velocity | Other | Study group |
| Urinary oxygen tension (PUO2)Urinary oxygen tension (PUO2) will be measured preoperatively (baseline), postoperatively just after intensive care unit admission, 12 hours after surgery, and then once daily for 7 days. | Other | Study group |
Primary outcome
Number of cases developed acute kidney injury
Time frame: 7 days after the procedure
Number of cases developed acute kidney injury as defined by KIDGO guidelines (serum creatinine ≥ 0.3 mg/dL from base line within 48 hours, or ≥1.5 fold within 7 days, or urine output <0.5 mL/kg/hour for six hours) in patients undergoing open heart surgery.
5 secondary outcomes
Length of intensive care unit stay
Time frame: 7 days after the procedure
Length of hospital stay
Time frame: 7 days after the procedure
Need for renal replacement therapy
Time frame: 7 days after the procedure
Number of patients developed chronic kidney disease
Time frame: 7 days after the procedure
Mortality rate
Time frame: 7 days after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- 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.
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.
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 Doppler-Based Renal Ultrasound and Urinary Oxygen Tension, 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amany M Badr, Master (00201018038038, amany.badr@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases developed acute kidney injury (time frame: 7 days after the procedure). 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 25 Jun 2025.