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

NCT07037485 | Recruiting

• 1 other identifier: 36265MD279/9/24
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  7 days after the procedure

Secondary Outcomes (5)

• Length of intensive care unit stay

  7 days after the procedure

• Length of hospital stay

  7 days after the procedure

• Need for renal replacement therapy

  7 days after the procedure

• Number of patients developed chronic kidney disease

  7 days after the procedure

• Mortality rate

  7 days after the procedure

Study Arms (1)

Study group

Patients undergoing elective on-pump cardiac surgery

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

Interventions

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

Study group

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

Study group

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Amany M Badr, Master

CONTACT

00201018038038; amany.badr@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)