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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04487262
Other study ID # 1-10-72-1-20
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date October 31, 2021

Study information

Verified date August 2023
Source Aarhus University Hospital Skejby
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rationale: Evidence regarding the timing of chest tube removal after cardiac surgery is sparse. The timing of chest tubes removal constitutes a balancing act between risk of retained blood syndrome, infection, patient discomfort and opioid-related side effects. Several studies have shown that chest tubes can safely be removed on the first postoperative day compared to later. A single retrospective study raised concern as chest tube removal on the day of surgery was associated with an increased requirement of drainage of pleural effusions. Primary Objective: To compare the impact of two standard chest tube removal protocols following open-heart surgery on the incidence of pleural and/or pericardial effusion requiring invasive drainage Secondary Objectives To evaluate the impact of chest tube removal on the day of surgery (DAY0) compared to the first postoperative day (DAY1) regarding: - Comsumption of analgetic drugs - Early postoperative pain - Incidence of infection - Early postoperative respiratory function Study design: Single-center, open, parallel-group, prospective, cluster-randomized controlled trial Alternate assignment of chest tube removal according to Day 0 versus Day 1 protocol based upon the month of surgery (even versus odd months). Study population: 1300 consecutive patients undergoing elective open heart surgery in full or lower hemisternotomy with or without cardiopulmonary bypass including coronary artery bypass grafting, valve surgery, simple aortic surgery or combinations.


Recruitment information / eligibility

Status Terminated
Enrollment 515
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All consecutive patients undergoing elective open heart surgery in full or lower hemisternotomy with or without cardiopulmonary bypass including coronary artery bypass grafting, valve surgery, simple aortic surgery or combinations. Exclusion Criteria: Cardiac procedures deemed not eligible to chest tube removal on the day of surgery due to increased bleeding risk due to: - Procedures in hypothermic circulatory arrest - Previous cardiac surgery - Procedures performed through upper hemisternotomy - Emergent treatment required (< 24 hours) - Non-aspirin antiplatelet drugs stopped < 5 days preoperatively (Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine) - Current use of vitamin K antagonists or new oral non-vitamin K anticoagulants - Platelet count > 450 or <100 x 109/l prior to surgery

Study Design


Intervention

Procedure:
Cardiac surgery
Elective open heart surgery

Locations

Country Name City State
Denmark Dep. of Cardiothoracic Surgery, Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Andreasen JJ, Sorensen GV, Abrahamsen ER, Hansen-Nord E, Bundgaard K, Bendtsen MD, Troelsen P. Early chest tube removal following cardiac surgery is associated with pleural and/or pericardial effusions requiring invasive treatment. Eur J Cardiothorac Surg. 2016 Jan;49(1):288-92. doi: 10.1093/ejcts/ezv005. Epub 2015 Feb 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of postoperative pleural and/or pericardial effusion Effusion requiring invasive drainage up to 30 days after surgery
Secondary Quantity of opiod consumption Measured as oral morphine equivalent daily dose (mg/day) During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
Secondary Quantity of non-steroidal anti-inflammatory drug consumption Daily dose of NSAIDs standardized by using the manufacturers' recommended minimum daily maintenance doses for rheumatoid arthritis as 1 dose unit During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
Secondary Intensity of postoperative pain Measured as NRS score: Scale 0 (no pain) to 10 (worst possible pain) Before and after first mobilization day 1
Secondary Amount of chest tube output measured in mL after 24 hours and up to removal (max. up to 30 days)
Secondary Rate re-exploration because of bleeding Re-exploration due to haemorrhage or signs of tamponade < 24 hours of surgery up to 30-day follow-up
Secondary Number of re-exploration due to tamponade Re-exploration due to clinical signs of tamponade > 24 hours after surgery up to 30-day follow-up
Secondary Time until chest tube removal Measured in hours after completed surgery In-hospital
Secondary Length of stay on cardiac surgery intensive care unit Number of nights In-hospital
Secondary Length of hospital stay after surgery Days up to 30-day follow-up
Secondary Rate of infection requiring antibiotic treatment: Number of:
Superficial wound infection (sternal or saphenous vein harvest site)
Deep wound infection (sternal or saphenous vein harvest site)
Pneumonia
Urinary tract infection
Antibiotic treatment for fever of unknown origin.
up to 30-day follow-up
Secondary Rate of new-onset atrial fibrillation New-onset postoperative atrial fibrillation requring intervention (drug or defibrillation) up to 30-day follow-up
Secondary Re-hospitalization due to pleural or pericardial effusion up to 30-day follow-up Number and length of stay up to 30-day follow-up
Secondary Rate of acute kidney injury Classified according to the Acute Kidney Injury Network (AKIN) classification:
Stage 1: Creatinine × 1.5 - 2.0 from baseline Stage 2: Creatinine × 2.0-3.0 (i.e. doubled or tripled creatinine) Stage 3: Creatinine > 3.0 x baseline level OR initiation of renal replacement therapy
up to 30-day follow-up
Secondary Duration of mechanical ventilation Measured in hours after completed surgery In-hospital (max up to 30 days)
Secondary Early postoperative respiratory function PaO2/FiO2 ratio after first mobilization day 1
Secondary Need for supplemental oxygen Days In-hospital (max up to 30 days)
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