NCT07044102

Brief Summary

Postoperative acute kidney injury following cardiopulmonary bypass surgery represents a significant barrier to patient recovery and is closely associated with increased postoperative morbidity and mortality. Studies have shown that the incidence of AKI aftercardiopulmonary bypass surgeryranges between 5% and 30%. The Renal Resistive Index, measured by Doppler ultrasonography, is an increasingly utilized parameter that provides valuable insights into renal hemodynamics and vascular resistance. A normal RRI is typically below 0.70; elevated values may indicate increased renal vascular resistance or microvascular damage. Bossard et al. demonstrated that increased RRI in the early postoperative period is associated with the development of AKI. Early evaluation of renal blood flow thus facilitates prompt detection of AKI. Both preoperative and postoperative RRI measurements are considered useful tools for identifying early renal dysfunction. Monitoring RRI before and after CABG may provide critical information for preventing postoperative renal complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

June 23, 2025

Last Update Submit

February 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Renal resistive ındex

    Measurement of Changes in Renal Resistive Index Associated With Low Tidal Volume and Apneic Ventilation

    Postoperative 45 minutes

Study Arms (2)

Patients Undergoing Low Tidal Volume Ventilation During CABG

EXPERIMENTAL

patients undergoing coronary artery bypass grafting receive continuous low tidal volume ventilation during cardiopulmonary bypass

Other: Patients Undergoing Low Tidal Volume Ventilation During CABG

Patients Managed With Apneic Ventilation During Cardiopulmonary Bypass"

ACTIVE COMPARATOR

patients undergoing coronary artery bypass grafting are managed with apnea ventilation during cardiopulmonary bypass

Other: Patients Undergoing Apneic Ventilation During CABG

Interventions

Postoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass

Patients Undergoing Low Tidal Volume Ventilation During CABG

Postoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass"

Patients Managed With Apneic Ventilation During Cardiopulmonary Bypass"

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective cardiac bypass surgery
  • Male and female patients over 18 years of age
  • Patients with an American Society of Anesthesiologists (ASA) physical status classification of II, III, or IV

You may not qualify if:

  • Chronic renal failure requiring dialysis
  • Patients requiring emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: participants are randomized in a parallel design to receive either continuous low tidal volume ventilation or conventional ventilation during cardiopulmonary bypass
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor, MD Anesthesiology and Reanimation

Study Record Dates

First Submitted

June 23, 2025

First Posted

June 29, 2025

Study Start

July 15, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations