Influence of a minimized extracorporeal circulation on angiopoietin-1 and -2, and other markers of endothelial activation, a diagnostic study
Organizational Data
- DRKS-ID:
- DRKS00008855
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2015-06-25
- Last update in DRKS:
- 2018-11-26
- Registration type:
- Prospective
Acronym/abbreviation of the study
/
URL of the study
Brief summary in lay language
In open-heart surgery patients need to be temporarily connected to a heart-lung machine, to ensure the circulation of the body. The contact of the patient's blood with the surfaces of the heart-lung machine leads to an activation of the body's inflammatory system with some potential side effects. There are for bypass surgery basically three methods: 1. normal hours of cardiopulmonary bypass, 2. a mini cardiopulmonary bypass and 3. surgery on the beating heart without the use of cardiopulmonary bypass. Which of the three methods is applied, it decides on an individual, regardless of the study. On the basis of operational data and blood samples, the surgical procedures are to be compared. With the targeted investigation of certain proteins that have a decisive influence on the recovery after such surgery, new insights into the predictability of complications after surgery with a connection to be gained in the cardiopulmonary bypass.
Brief summary in scientific language
In applying a conventional cardiopulmonary bypass (CPB), there is an endothelial activation. Angiopoietin-2 was identified as a possible mediator of CPB-induced endothelial barrier dysfunction. Minimized extracorporeal perfusion systems (so-called. Minimized Perfusion Circuit, MPC) appear against CPB to have advantages in terms of organ dysfunction, but it is unclear whether MPC and the surgery without extracorporeal circulation (off-pump) are associated with reduced endothelial markers. It is believed that Angiopoietin-2 (Angpt-2) and other markers of endothelial activation by MPC or off-pump surgery (OPCAB) in comparison with conventional CPB is reduced. The aim of the prospective diagnostic study is the characterization of endothelial activation and the capillary leak by measuring of angiopoietin-1 and -2 (and possibly other Inflammationsparametern) by ELISA as well as the comparative analysis of the parameters collected for significant differences between the groups CPB, OPCAB and MPC.
Health condition or problem studied
- ICD10:
- I25.13
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- In patients with the need for coronary bypass surgery EDTA blood (plasma) is taken at the following times: a. before connecting to the extracorporeal circulation (after opening the pericardium during OPCAB) b. following the departure of the extracorporeal circulation, c. 24 hours after departure from extracorporeal circulation and d. 72h after disposal of extracorporeal circulation. The samples are stored at -80 ° C and there is a measure of angiopoietin-1 and -2 (and possibly other inflammatory marker) by ELISA to an evaluation of the parameters collected for significant differences between the groups CPB, OPCAB and MPC.
Endpoints
- Primary outcome:
- Diagnosis of angiopoietin-1 and -2 as well as other inflammatory and endothelial marker
- Secondary outcome:
- - Vital and laboratory values of the first 72h - fluid balance of the first 72 hours - Katecholamindosen the first 72h - organ dysfunction (Sequential Organ Failure Assessment [SOFA] and other scores) - consumption of blood products - hospital stays and intensive care hospital - survival - Quality of Life
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Herz- und Thoraxchirurgie Magdeburg
Recruitment period and number of participants
- Planned study start date:
- 2015-07-01
- Actual study start date:
- 2015-08-06
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2016-09-30
- Target Sample Size:
- 150
- Final Sample Size:
- 75
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Coronary of extracorporeal circulation - Age> 18 years - Written consent
Exclusion Criteria
- Pre-existing rheumatic or chronic infectious disease (such as systemic lupus erythematosus, ANCA-positive vasculitis, rheumatoid arthritis, etc.) - Certain medications (cortisol, immunosuppressants, ongoing oncological therapy) - major surgery in the last 3 months - renal insufficiency stage 3 or higher (GFR <60ml / min)
Addresses
Primary Sponsor
- Address:
- Universitätsklinik für Herz- und ThoraxchirurgieProf. Dr. med. Ingo KutschkaLeipziger Str. 4439112 MagdeburgGermany
- Telephone:
- +49-391-6714100
- Fax:
- +49-391-6714127
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinik für Herz- und ThoraxchirurgieDr. med. Johannes HademLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- +49-391-6714132
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinik für Herz- und ThoraxchirurgieDr. med. Johannes HademLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- +49-391-6714132
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinik für Herz- und ThoraxchirurgieDr. med. Johannes HademLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- +49-391-6714132
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinik für Herz- und ThoraxchirurgieLeipziger Str. 4439112 MagdeburgGermany
- Telephone:
- +49-391-6714100
- Fax:
- +49-391-6714127
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.Leipziger Str. 44 Haus 2839120 MagdeburgGermany
- Telephone:
- +49-391-6714314
- Fax:
- +49-391-67290185
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-04-10
- Ethics committee number:
- 51/15
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-04-29
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Hadem, J. et al.: Endothelial dysfunction following coronary artery bypass grafting : Influence of patient and procedural factors. Herz. May 2018
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry