Heart SurgeryNCT04487262
Timing for Removal of Chest Tubes in Adult Cardiac Surgery
A study testing Cardiac surgery in people with Heart Surgery and Chest Tube, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgery, Chest Tube, Effusion Pleural
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 31 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dep. of Cardiothoracic Surgery, Aarhus University Hospital
Aarhus, 8200
About this study
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.
Read more
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.
- Conditions
- Heart Surgery, Chest Tube, Effusion Pleural, Pain, Postoperative
- Being tested
- Cardiac surgery
- Keywords
- Surgery, Heart, Chest Tube, Effusion, Pleural, Complications, Postoperative, Pain, Postoperative
- Medical subject headings
- Pleural Effusion, Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
Elective open heart surgery
| Study group | Role | What they receive |
|---|---|---|
| Day O chest tube removal | Active comparator | Chest tubes maybe removed ten hours after arrival at the intensive care provided standardized removal criteria are fulfilled:
1. blood loss through chest tubes less than 200 ml during the last four hours
2. no air leak
3. the patient extubated and mobilized It remains at the discretion of the attending cardiac surgeon to postpone chest tube removal in cases of increased bleeding risk, due to circumstances which develop during the perioperative period Receives: Procedure: Cardiac surgery |
| Day 1 chest tube removal | Active comparator | Chest tubes are removed in the early morning of the first postoperative day, provided standardized removal criteria are fulfilled:
1. blood loss through chest tubes less than 200 ml during the last four hours
2. no air leak
3. the patient extubated and mobilized It remains at the discretion of both the attending surgeon and anestesiologist to remove chest tubes prematurely in cases of drain-induced, severe analgetic resistant, intractable pain resistant to analgetic treatment. Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative pleural and/or pericardial effusion
Effusion requiring invasive drainage
Measured: up to 30 days after surgery
Secondary outcomes (16)
Quantity of opiod consumption
Measured as oral morphine equivalent daily dose (mg/day)
Measured: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
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
Measured: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
Intensity of postoperative pain
Measured as NRS score: Scale 0 (no pain) to 10 (worst possible pain)
Measured: Before and after first mobilization day 1
Amount of chest tube output
measured in mL
Measured: after 24 hours and up to removal (max. up to 30 days)
Rate re-exploration because of bleeding
Re-exploration due to haemorrhage or signs of tamponade < 24 hours of surgery
Measured: up to 30-day follow-up
Number of re-exploration due to tamponade
Re-exploration due to clinical signs of tamponade > 24 hours after surgery
Measured: up to 30-day follow-up
Time until chest tube removal
Measured in hours after completed surgery
Measured: In-hospital
Length of stay on cardiac surgery intensive care unit
Number of nights
Measured: In-hospital
Length of hospital stay after surgery
Days
Measured: up to 30-day follow-up
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.
Measured: up to 30-day follow-up
Rate of new-onset atrial fibrillation
New-onset postoperative atrial fibrillation requring intervention (drug or defibrillation)
Measured: up to 30-day follow-up
Re-hospitalization due to pleural or pericardial effusion up to 30-day follow-up
Number and length of stay
Measured: up to 30-day follow-up
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
Measured: up to 30-day follow-up
Duration of mechanical ventilation
Measured in hours after completed surgery
Measured: In-hospital (max up to 30 days)
Early postoperative respiratory function
PaO2/FiO2 ratio
Measured: after first mobilization day 1
Need for supplemental oxygen
Days
Measured: In-hospital (max up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Sep 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Why it stopped: Safety interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart SurgeryStudies 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
- Prospective cluster-randomized parallel study
- Masking
- None (open label)
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivy susanne Modrau, MD, Aarhus University Hospital Skejby
- Investigators
- Ivy Susanne Modrau, MD, dr.med., Principal investigator, Consultant Cardiac Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487262
- Sponsor's protocol ID
- 1-10-72-1-20
- Status last verified
- Aug 2023
- First submitted
- 16 Jul 2020
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual-level deidentified patient data that support the findings of this study, and statistical analysis plan are available upon reasonable request.
Publications
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.
PubMed 25661079
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing for Removal of Chest Tubes in Adult Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04487262
- Acronym / sponsor ID
- 1-10-72-1-20
- Conditions
- Heart Surgery, Chest Tube, Effusion Pleural, Pain, Postoperative
- Keywords
- Surgery, Heart, Chest Tube, Effusion, Pleural, Complications, Postoperative, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety interim analysis
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 27 Jul 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective cluster-randomized parallel study
| Arm | Type | Receives |
|---|---|---|
| Day O chest tube removal | Active comparator | Procedure: Cardiac surgeryChest tubes maybe removed ten hours after arrival at the intensive care provided standardized removal criteria are fulfilled: 1. blood loss through chest tubes less than 200 ml during the last four hours 2. no air leak 3. the patient extubated and mobilized It remains at the discretion of the attending cardiac surgeon to postpone chest tube removal in cases of increased bleeding risk, due to circumstances which develop during the perioperative period |
| Day 1 chest tube removal | Active comparator | Procedure: Cardiac surgeryChest tubes are removed in the early morning of the first postoperative day, provided standardized removal criteria are fulfilled: 1. blood loss through chest tubes less than 200 ml during the last four hours 2. no air leak 3. the patient extubated and mobilized It remains at the discretion of both the attending surgeon and anestesiologist to remove chest tubes prematurely in cases of drain-induced, severe analgetic resistant, intractable pain resistant to analgetic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Cardiac surgeryElective open heart surgery | Procedure or surgery | Day 1 chest tube removal, Day O chest tube removal |
Primary outcome
Rate of postoperative pleural and/or pericardial effusion
Time frame: up to 30 days after surgery
Effusion requiring invasive drainage
16 secondary outcomes
Quantity of opiod consumption
Time frame: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
Quantity of non-steroidal anti-inflammatory drug consumption
Time frame: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
Intensity of postoperative pain
Time frame: Before and after first mobilization day 1
Amount of chest tube output
Time frame: after 24 hours and up to removal (max. up to 30 days)
Rate re-exploration because of bleeding
Time frame: up to 30-day follow-up
Number of re-exploration due to tamponade
Time frame: up to 30-day follow-up
Time until chest tube removal
Time frame: In-hospital
Length of stay on cardiac surgery intensive care unit
Time frame: In-hospital
Length of hospital stay after surgery
Time frame: up to 30-day follow-up
Rate of infection requiring antibiotic treatment:
Time frame: up to 30-day follow-up
Rate of new-onset atrial fibrillation
Time frame: up to 30-day follow-up
Re-hospitalization due to pleural or pericardial effusion up to 30-day follow-up
Time frame: up to 30-day follow-up
Rate of acute kidney injury
Time frame: up to 30-day follow-up
Duration of mechanical ventilation
Time frame: In-hospital (max up to 30 days)
Early postoperative respiratory function
Time frame: after first mobilization day 1
Need for supplemental oxygen
Time frame: In-hospital (max up to 30 days)
Results and safety
The study was stopped early (reason given: Safety interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 25661079Andreasen 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.
- Individual participant dataSharing planned: Yes. Individual-level deidentified patient data that support the findings of this study, and statistical analysis plan are available upon reasonable request.
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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.
Ivy Susanne Modrau, MD, dr.med. principal investigator
Consultant Cardiac Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac surgery in people with Heart Surgery and Chest Tube, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Aug 2023. 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 Denmark. 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 was stopped early (reason given: Safety interim analysis). Results are not available in the source record.
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?
Rate of postoperative pleural and/or pericardial effusion (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487262, which also lists 1 linked publication.
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 8 Aug 2023.