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RecruitingNCT07037485Updated Jun 25, 2025

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 in Doppler-Based Renal Ultrasound, Urinary Oxygen Tension and Acute Kidney Injury, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by Tanta University · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
21 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Doppler-Based Renal Ultrasound
  • Urinary Oxygen Tension
  • Acute Kidney Injury
  • Open Heart Surgery

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03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Age above 21 years.
  • Both sexes.
  • Undergoing elective on-pump cardiac surgery.

Exclusion criteria

Exclusion Criteria:

  • Patients with chronic kidney disease.
  • Patients with any renal pathology or anatomic kidney abnormalities.
  • Patients on renal replacement therapy.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study group

    Patients undergoing elective on-pump cardiac surgery

    Other: Renal resistive index · Other: Renal Artery Pulsatility Index · Other: Urinary oxygen tension (PUO2)

Interventions

  • OtherRenal resistive index

    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

  • OtherRenal Artery Pulsatility Index

    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

  • OtherUrinary 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days after the procedure

Secondary outcomes

  1. 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.

    Time frame: 7 days after the procedure

  2. Length of hospital stay

    Length of hospital stay will be measured from admission till discharge from hospital.

    Time frame: 7 days after the procedure

  3. Need for renal replacement therapy

    Need for renal replacement therapy will be recorded.

    Time frame: 7 days after the procedure

  4. Number of patients developed chronic kidney disease

    Number of patients developed chronic kidney disease will be recorded.

    Time frame: 7 days after the procedure

  5. Mortality rate

    Mortality rate will be recorded.

    Time frame: 7 days after the procedure

07

Study locations

1 of 1 sites recruiting
  • Tanta University
    Tanta, El-Gharbia 31527, Egypt
    • Amany M Badr, Master · Contact · amany.badr@med.tanta.edu.eg · 00201018038038
    • Ayman A Yousef, MD · Sub investigator
    • Sabry M Amin, MD · Sub investigator
    • Rabab M Mohammed, MD · Sub investigator
    • Aliaa M Belal, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07037485
Lead sponsor
Tanta University
Responsible party
Amany Mohamed Badr Ali Badr (Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt, Tanta University) — Principal investigator
First posted
Jun 25, 2025
Start date
Oct 1, 2024
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Jun 25, 2025

Study contacts

Amany M Badr, Master
Contact
amany.badr@med.tanta.edu.eg
00201018038038

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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