- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07044102
- Original Trial
The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Renal Resistive Index
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.
Study Overview
Status
Conditions
Detailed Description
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 after CABG ranges 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.In recent years, significant advancements have been made in both surgical and anesthetic techniques in cardiac surgery. During CABG, the commonly used ventilation strategy during cardiopulmonary bypass is apneic ventilation. However, low tidal volume ventilation has been proposed as an alternative, with a growing body of literature supporting its use. LTV has been associated with reduced postoperative pulmonary complications, earlier extubation, and prevention of atelectasis and pulmonary edema.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey (Türkiye)
- Konya City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Chronic renal failure requiring dialysis
- Patients requiring emergency surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients Undergoing Low Tidal Volume Ventilation During CABG
patients undergoing coronary artery bypass grafting receive continuous low tidal volume ventilation during cardiopulmonary bypass
|
Postoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass
|
|
Active Comparator: Patients Managed With Apneic Ventilation During Cardiopulmonary Bypass"
patients undergoing coronary artery bypass grafting are managed with apnea ventilation during cardiopulmonary bypass
|
Postoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal resistive ındex
Time Frame: Postoperative 45 minutes
|
Measurement of Changes in Renal Resistive Index Associated With Low Tidal Volume and Apneic Ventilation
|
Postoperative 45 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bypass surgery
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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