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NCT Number: NCT07037485

The Predictive Value of Doppler Based Renal Ultrasound and Urinary Oxygen Tension for Prediction of Acute Kidney Injury After Open Heart Surgery

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Aliaa M Belal, MD

SUB_INVESTIGATOR

Amany M Badr, Master

CONTACT

[email protected]

00201018038038

Ayman A Yousef, MD

SUB_INVESTIGATOR

Rabab M Mohammed, MD

SUB_INVESTIGATOR

Sabry M Amin, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Renal resistive index

Other

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 Index

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Length of intensive care unit stay

    Time frame: 7 days after the procedure

    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.

  2. Length of hospital stay

    Time frame: 7 days after the procedure

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

  3. Need for renal replacement therapy

    Time frame: 7 days after the procedure

    Need for renal replacement therapy will be recorded.

  4. Number of patients developed chronic kidney disease

    Time frame: 7 days after the procedure

    Number of patients developed chronic kidney disease will be recorded.

  5. Mortality rate

    Time frame: 7 days after the procedure

    Mortality rate will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Amany M Badr, Master

CONTACT

[email protected]

00201018038038

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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