NCT01614951

Brief Summary

The purpose of this study is to investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation capacity after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

June 6, 2012

Last Update Submit

April 24, 2014

Conditions

Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (1)

  • Oxygenation Index

    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).

    From pre operation until 24 hours post operation

Study Arms (3)

Pulmonary perfusion

EXPERIMENTAL
Procedure: Perfusion of the lungs

Pulmoplegia

EXPERIMENTAL
Drug: HTK Custodiol

Control group

OTHER
Other: Standard ECC

Interventions

Perfusion of the lungsPROCEDURE

Pulmonary perfusion with oxygenated blood during ECC.

Pulmonary perfusion
HTK CustodiolDRUG

Pulmoplegia before ECC.

Pulmoplegia
Standard ECCOTHER

ECC after standard procedure

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen N, 2200, Denmark

Location

Related Publications (4)

  • Risom EC, Buggeskov KB, Mogensen UB, Sundskard M, Mortensen J, Ravn HB. Preoperative pulmonary function in all comers for cardiac surgery predicts mortalitydagger. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):244-251. doi: 10.1093/icvts/ivz049. Epub 2019 Mar 15.

    PMID: 30879046DERIVED

  • Buggeskov KB, Sundskard MM, Jonassen T, Andersen LW, Secher NH, Ravn HB, Steinbruchel DA, Jakobsen JC, Wetterslev J. Pulmonary artery perfusion versus no pulmonary perfusion during cardiopulmonary bypass in patients with COPD: a randomised clinical trial. BMJ Open Respir Res. 2016 Sep 6;3(1):e000146. doi: 10.1136/bmjresp-2016-000146. eCollection 2016.

    PMID: 27651908DERIVED

  • Buggeskov KB, Jakobsen JC, Secher NH, Jonassen T, Andersen LW, Steinbruchel DA, Wetterslev J. Detailed statistical analysis plan for the pulmonary protection trial. Trials. 2014 Dec 23;15:510. doi: 10.1186/1745-6215-15-510.

    PMID: 25539792DERIVED

  • Buggeskov KB, Wetterslev J, Secher NH, Andersen LW, Jonassen T, Steinbruchel DA. Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial. Trials. 2013 Jan 31;14:30. doi: 10.1186/1745-6215-14-30.

    PMID: 23363494DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Bretschneider cardioplegic solution

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel A. Steinbrüchel, prof.

    Rigshospitalet, Thoracic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. med.

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

DK(1)