Postoperative ComplicationsNCT07044102
The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Renal Resistive Index
A study testing Patients Undergoing Low Tidal Volume Ventilation During CABG and Patients Undergoing Apneic Ventilation During CABG in people with Postoperative Complications, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Patients Undergoing Low Tidal Volume Ventilation During CABG and Patients Undergoing Apneic Ventilation During CABG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic renal failure requiring dialysis
- Patients requiring emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postoperative Complications
- Being tested
- Patients Undergoing Low Tidal Volume Ventilation During CABG, Patients Undergoing Apneic Ventilation During CABG
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients Undergoing Low Tidal Volume Ventilation During CABGOther
Postoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass
Patients Undergoing Apneic Ventilation During CABGOther
Postoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass"
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Low Tidal Volume Ventilation During CABG | Experimental | patients undergoing coronary artery bypass grafting receive continuous low tidal volume ventilation during cardiopulmonary bypass Receives: 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 Receives: Other: Patients Undergoing Apneic Ventilation During CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal resistive ındex
Measurement of Changes in Renal Resistive Index Associated With Low Tidal Volume and Apneic Ventilation
Measured: Postoperative 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start15 Jul 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants are randomized in a parallel design to receive either continuous low tidal volume ventilation or conventional ventilation during cardiopulmonary bypass
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra GÖGER, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044102
- Sponsor's protocol ID
- bypass surgery
- Status last verified
- Feb 2026
- First submitted
- 23 Jun 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Renal Resistive Index
- ClinicalTrials.gov ID
- NCT07044102
- Acronym / sponsor ID
- bypass surgery
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants are randomized in a parallel design to receive either continuous low tidal volume ventilation or conventional ventilation during cardiopulmonary bypass
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Low Tidal Volume Ventilation During CABG | Experimental | Other: Patients Undergoing Low Tidal Volume Ventilation During CABGpatients undergoing coronary artery bypass grafting receive continuous low tidal volume ventilation during cardiopulmonary bypass |
| Patients Managed With Apneic Ventilation During Cardiopulmonary Bypass" | Active comparator | Other: Patients Undergoing Apneic Ventilation During CABGpatients undergoing coronary artery bypass grafting are managed with apnea ventilation during cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Chronic renal failure requiring dialysis
- Patients requiring emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients Undergoing Low Tidal Volume Ventilation During CABGPostoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass | Other | Patients Undergoing Low Tidal Volume Ventilation During CABG |
| Patients Undergoing Apneic Ventilation During CABGPostoperative Evaluation of Renal Resistive Index Using Doppler Ultrasound After Cardiopulmonary Bypass" | Other | Patients Managed With Apneic Ventilation During Cardiopulmonary Bypass" |
Primary outcome
Renal resistive ındex
Time frame: Postoperative 45 minutes
Measurement of Changes in Renal Resistive Index Associated With Low Tidal Volume and Apneic Ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients Undergoing Low Tidal Volume Ventilation During CABG and Patients Undergoing Apneic Ventilation During CABG in people with Postoperative Complications, run by Konya City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal resistive ındex (time frame: Postoperative 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.