Early Outcomes of Spontaneous vs. Negative-pressure Drainage After Coronary Artery Bypass Grafting

NCT07814573 | Active Not Recruiting

• 1 other identifier: 123
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 coronary artery bypass grafting (CABG).

Conditions

Drainage; Complications Due to Coronary Artery Bypass Graft; Coronary Artery Bypass Graft (CABG)

Keywords

drainage; cabg; coronary artery bypass graft; cardiovascular surgery; cardiac surgery

Outcome Measures

Primary Outcomes (3)

• Pre-discharge echocardiographic assessment

  Pericardial effusion volume and left ventricular ejection fraction (LVEF) measured in percentage (%) via transthoracic echocardiography prior to hospital discharge.

  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.

  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.

  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

  from surgery to discharge (5-30 days)

• Duration of intubation

  10-360 hours

Study Arms (2)

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

Procedure: monitoring of drainage using negative pressure

Interventions

monitoring of drainage using negative pressure PROCEDURE

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).

Negative Pressure Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam Ve Sakura Şehir Hastanesi

Istanbul, Istanbul, 34480, Turkey (Türkiye)

Location

Study Officials

• Süleyman Yazıcı, MD, Assoc. Prof.

  BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular Surgery Resident

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)