The Pulmonary Protection Trial
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ClinicalTrials.gov Identifier: NCT01614951 |
Recruitment Status :
Completed
First Posted : June 8, 2012
Last Update Posted : April 25, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Lung Disease | Procedure: Perfusion of the lungs Drug: HTK Custodiol Other: Standard ECC | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Pulmonary perfusion |
Procedure: Perfusion of the lungs
Pulmonary perfusion with oxygenated blood during ECC. |
Experimental: Pulmoplegia |
Drug: HTK Custodiol
Pulmoplegia before ECC. |
Control group |
Other: Standard ECC
ECC after standard procedure |
- Oxygenation Index [ Time Frame: From pre operation until 24 hours post operation ]To investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation index after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
Planned and urgent surgery on legally competent patients over 18 years:
- Coronary Artery Bypass Graft Surgery
- Aortic Valve Replacement
- Coronary Artery Bypass Graft Surgery + Aortic Valve Replacement
- Transcatheter Aortic-Valve Implantation
- Spirometry FEV1 measurement show less than or equal to 80% of the anticipated. We expect that these patients provide the largest signal with lung protective interventions in relation to lung healthy patients.
Exclusion Criteria:
- Previous surgery on the heart or lungs
- Previous thoracic irradiation
- Preoperative heart failure (ejection fraction below 20%).
- Surgical demanding mitral regurgitation
- Unstable patients (heart rate above 100 and systolic blood pressure below 100 mmHg)
- Intubated patients
- Patients with an ongoing preoperative treatment with antibiotics for suspected pneumonia.
- Patients with renal insufficiency requiring hemodialysis
- Pregnant and lactating

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614951
Denmark | |
Rigshospitalet | |
Copenhagen N, Denmark, 2200 |
Principal Investigator: | Daniel A. Steinbrüchel, prof. | Rigshospitalet, Thoracic Surgery |
Responsible Party: | Daniel Steinbruchel, Prof. dr. med., Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT01614951 |
Other Study ID Numbers: |
4141 2011-006290-25 ( EudraCT Number ) 4141 ( Other Identifier: EudraCT Protocol kode ) H-1-2012-0 24 ( Other Identifier: The Danish Scientific Ethical Committee protocol code ) 2007-58-0015. ( Other Identifier: The Danish Data Protection Agency journal number ) |
First Posted: | June 8, 2012 Key Record Dates |
Last Update Posted: | April 25, 2014 |
Last Verified: | April 2014 |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |