NCT07821983

Brief Summary

Acute kidney injury can occur after coronary artery bypass grafting (CABG). This prospective, single-center observational study will evaluate whether two measurements obtained from renal Doppler ultrasound-the renal augmented velocity index (AVI) and renal resistive index (RRI)-can help predict postoperative acute kidney injury. About 200 adults undergoing elective isolated CABG with cardiopulmonary bypass will have bilateral renal Doppler examinations one day before surgery, within 60 minutes after admission to the intensive care unit, and 6 hours after intensive care unit admission. The primary outcome is acute kidney injury within the first 7 days after surgery, defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Ultrasound measurements will be analyzed offline and will not influence clinical care.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Sep 2027

First Submitted

Initial submission to the registry

September 10, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

September 10, 2026

Last Update Submit

September 10, 2026

Conditions

Keywords

renal augmented velocity indexrenal resistive indexrenal Doppler ultrasonographyacute kidney injurycoronary artery bypass graftingcardiac surgeryKDIGOprognostic biomarker

Outcome Measures

Primary Outcomes (1)

  • Incidence of Acute Kidney Injury According to KDIGO Criteria

    Number and percentage of participants who develop acute kidney injury according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria, based on serum creatinine and/or urine output.

    From surgery through postoperative day 7

Secondary Outcomes (9)

  • Incidence of KDIGO Stage 2 or 3 Acute Kidney Injury

    From surgery through postoperative day 7

  • Need for Renal Replacement Therapy

    During the index hospitalization, up to 30 days after surgery

  • Duration of Mechanical Ventilation

    During the index hospitalization, up to 30 days after surgery

  • Intensive Care Unit Length of Stay

    During the index hospitalization, up to 30 days after surgery

  • Hospital Length of Stay

    During the index hospitalization, up to 30 days after surgery

  • +4 more secondary outcomes

Study Arms (1)

Elective Isolated On-Pump CABG Cohort

Adults scheduled for elective isolated coronary artery bypass grafting with cardiopulmonary bypass. Bilateral renal Doppler ultrasonography is performed one day before surgery and at 0 and 6 hours after ICU admission. Renal augmented velocity index and renal resistive index measurements are analyzed offline and are not used to guide clinical care.

Diagnostic Test: Renal Doppler Ultrasonography

Interventions

Bilateral renal Doppler examinations are performed at T0 (one day before surgery after at least 10 minutes of rest), T1 (within the first 60 minutes after postoperative ICU admission), and T2 (6 hours after ICU admission). Renal augmented velocity index and renal resistive index are calculated offline from stored waveforms. Study measurements do not guide clinical care.

Also known as: Renal Doppler Ultrasound
Elective Isolated On-Pump CABG Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults scheduled for elective isolated on-pump coronary artery bypass grafting at Bursa Yuksek Ihtisas Training and Research Hospital who meet all eligibility criteria. Consecutive eligible patients will be approached before surgery.

You may qualify if:

  • Age 18 years or older.
  • Scheduled for elective isolated coronary artery bypass grafting with cardiopulmonary bypass (on-pump).
  • Able and willing to provide written informed consent.
  • Both kidneys present.
  • Adequate bilateral preoperative renal Doppler signal for study measurements.

You may not qualify if:

  • Preoperative chronic dialysis or renal replacement therapy.
  • Urgent or emergency surgery.
  • Combined cardiac surgery, including valve, aortic, or another major additional procedure.
  • Off-pump coronary artery bypass grafting or conversion of the planned surgical technique.
  • Clinically significant rhythm disturbance preventing acquisition of three interpretable cardiac cycles.
  • Renal transplant, solitary kidney, significant renal artery stenosis, previous renal artery intervention, hydronephrosis, or other relevant renal vascular or structural disease.
  • Inadequate bilateral preoperative renal Doppler examination.
  • Withdrawal of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Kidney InjuryCoronary Artery Disease

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Nuri Burkay Soylu, MD

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuri Burkay Soylu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Specialist Physician

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 16, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 16, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared outside the study team. Access will be limited to the investigators specified in the approved study protocol.

Locations