DrainageNCT07814573
Early Outcomes of Spontaneous vs. Negative-pressure Drainage After Coronary Artery Bypass Grafting
A study testing monitoring of drainage using negative pressure in people with Drainage and Complications Due to Coronary Artery Bypass Graft, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this prospective, randomized controlled clinical trial is to evaluate early postoperative outcomes and fluid drainage dynamics between continuous active negative-pressure chest drainage (-10 mmHg) and standard spontaneous closed underwater-seal drainage in adult patients undergoing elective isolated… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drainage, Complications Due to Coronary Artery Bypass Graft, Coronary Artery Bypass Graft (CABG)
- What is being tested?
- monitoring of drainage using negative pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 15 Sep 2027
- Phase
- Interventional
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective, isolated coronary artery bypass grafting (CABG) via median sternotomy.
- Adult patients aged from 18 to 80 years.
- Patients who provide written informed consent prior to study enrollment.
Who cannot join
- Patients undergoing emergency coronary artery bypass grafting (CABG) or emergency surgical re-exploration.
- Patients under 18 years or over 80 years of age.
- Patients undergoing re-do cardiac surgery.
- Pre-existing pericardial effusion or significant pleural effusion detected on baseline imaging.
- Pre-existing baseline coagulopathy or active bleeding disorder.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam Ve Sakura Şehir Hastanesi
Istanbul, Istanbul, 34480
About this study
Official title: Comparison of Early-stage Outcomes of Spontaneous Drainage Versus Negative-pressure Drainage Monitoring in Patients Undergoing Coronary Artery Bypass Grafting: a Prospective Randomized Controlled Study
The purpose of this prospective, randomized controlled clinical trial is to evaluate early postoperative outcomes and fluid drainage dynamics between continuous active negative-pressure chest drainage (-10 mmHg) and standard spontaneous closed underwater-seal drainage in adult patients undergoing elective isolated coronary artery bypass grafting (CABG).
Read the detailed description
Postoperative pericardial and pleural fluid accumulation following cardiac surgery can lead to complications such as postoperative atrial fibrillation (POAF), cardiac tamponade, or symptomatic pleural effusion. While low-intensity negative-pressure suction is commonly used in general thoracic procedures, its routine application in cardiac surgery remains debated.This prospective randomized study evaluates whether maintaining continuous low-intensity active negative-pressure chest drainage (-10mmHg) during the first 48 hours postoperatively improves early fluid evacuation and reduces early morbidity compared with conventional spontaneous closed underwater-seal chest drainage.
- Conditions
- Drainage, Complications Due to Coronary Artery Bypass Graft, Coronary Artery Bypass Graft (CABG)
- Being tested
- monitoring of drainage using negative pressure
- Keywords
- drainage, cabg, coronary artery bypass graft, cardiovascular surgery, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring of drainage using negative pressureProcedure or surgery
Continuous low-intensity active negative-pressure suction (-10mmHg) applied to chest drains via central vacuum wall suction for the first 48 hours postoperatively following coronary artery bypass grafting (CABG).
| Study group | Role | What they receive |
|---|---|---|
| No-Negative Pressure Group | No intervention | patients not subjected to negative pressure and managed with routine underwater-seal drainage |
| Negative Pressure Group | Active comparator | patients monitored under negative pressure Receives: Procedure: monitoring of drainage using negative pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-discharge echocardiographic assessment
Pericardial effusion volume and left ventricular ejection fraction (LVEF) measured in percentage (%) via transthoracic echocardiography prior to hospital discharge.
Measured: 7-14 days after the surgery
Cumulative drainage volume at 24 and 48 hours
Total volume of thoracic drainage fluid measured in milliliters (mL) at 24 and 48 hours postoperatively.
Measured: First 24 and 48 hours after the surgery
Incidence of postoperative complications
Rate of early complications occurring within 48 hours postoperatively, including postoperative atrial fibrillation (POAF), pneumothorax, and symptomatic pleural effusion requiring intervention.
Composite rate of major complications within 30 days postoperatively, including surgical re-exploration for bleeding or cardiac tamponade, requirement for extracorporeal membrane oxygenation (ECMO) support, deep sternal wound infection or sternal revision, and 30-day all-cause mortality.
Measured: It will be evaluated during the patient follow-ups at the first 48 hours and the one-month check-ups.
Secondary outcomes (2)
Postoperative recovery metrics
Intensive care unit (ICU) length of stay and total hospital length of stay measured in days
Measured: from surgery to discharge (5-30 days)
Duration of intubation
the time elapsed from the point of intubation at the start of the operation until extubation
Measured: 10-360 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Sep 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrainageStudies 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
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emre Doğan, Başakşehir Çam & Sakura City Hospital
- Investigators
- Süleyman Yazıcı, MD, Assoc. Prof., Study director, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814573
- Sponsor's protocol ID
- 123
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data cannot be shared with third parties, as specified during the ethics committee application.