Postoperative Wound InfectionAlgebraNCT01184430
Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery
A study testing Pulse contour cardiac output device in people with Postoperative Wound Infection and Postoperative Outcome, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Cardiac surgery patients have a high risk to suffer from postoperative infections. Some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Wound Infection, Postoperative Outcome
- What is being tested?
- Pulse contour cardiac output device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Dec 2014
- 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
- elective cardiac surgery patient undergoing cardiopulmonary bypass
- signed informed consent
Who cannot join
- pregnant or breast feeding women
- Age <18 years
- pulmonary disease with an oxygenation index <300mmHg
- liver disease (>Child B)
- HIV-Infection
- Therapy with corticosteroids
- Condition after transplantation
- preexisting infection before operation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Berlin, 10117
Michael Sander, MD, +4930 450 531 ext. 052, Michael.Sander@charite.de
Michael Sander, MD
About this study
Official title: Monocentric Pilot Study of Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery
Cardiac surgery patients have a high risk to suffer from postoperative infections. Some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. Monocytes in the blood and, especially alveolar macrophages are important for an adequate host defence. In studies the investigators have shown that hemodynamic parameters have a significant influence on the probability to develop postoperative infections. The aim of the study is to investigate, whether cardiac surgery patients have an altered immune function after surgery that is predictive for the latter development of subsequent infections and whether they benefit from a goal-directed volume and hemodynamic therapy.
- Being tested
- Pulse contour cardiac output device
- Keywords
- advanced hemodynamic monitoring, goal-directed therapy, cardiac surgery, hemodynamic monitoring
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse contour cardiac output deviceDevice
Also called Non calibrated pulse contour cardiac output monitor
Goal directed volume therapy using stroke volume variation and cardiac output to guide volume therapy and inotropic support.
| Study group | Role | What they receive |
|---|---|---|
| advanced hemodynamic monitoring | Active comparator | advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy Receives: Device: Pulse contour cardiac output device |
| standard monitoring | No intervention | hemodynamic monitoring based on the standard operating procedures of our clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
HLA-DR Expression on monocytes after surgery
Measured: 24 hours
Secondary outcomes (1)
ICU stay
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2013
- Primary completionMar 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Wound InfectionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sander, Charite University, Berlin, Germany
- Investigators
- Michael Sander, MD, Principal investigator, Dept. of Anesthesiology Charité Universitaetsmedizin BerlinClaudia Spies, MD, Study chair, Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184430
- Sponsor's protocol ID
- Algebra
- Acronym
- Algebra
- Status last verified
- Aug 2013
- First submitted
- 17 Aug 2010
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Pilot Study of Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01184430
- Acronym / sponsor ID
- Algebra / Algebra
- Keywords
- advanced hemodynamic monitoring, goal-directed therapy, cardiac surgery, hemodynamic monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 Aug 2010 (estimated)
- 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.
Cardiac surgery patients have a high risk to suffer from postoperative infections. Some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. Monocytes in the blood and, especially alveolar macrophages are important for an adequate host defence. In studies the investigators have shown that hemodynamic parameters have a significant influence on the probability to develop postoperative infections. The aim of the study is to investigate, whether cardiac surgery patients have an altered immune function after surgery that is predictive for the latter development of subsequent infections and whether they benefit from a goal-directed volume and hemodynamic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| advanced hemodynamic monitoring | Active comparator | Device: Pulse contour cardiac output deviceadvanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy |
| standard monitoring | No intervention | –hemodynamic monitoring based on the standard operating procedures of our clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective cardiac surgery patient undergoing cardiopulmonary bypass
- signed informed consent
Key exclusion criteria (8 listed)
- pregnant or breast feeding women
- Age <18 years
- pulmonary disease with an oxygenation index <300mmHg
- liver disease (>Child B)
- HIV-Infection
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 |
|---|---|---|
| Pulse contour cardiac output deviceAlso: Non calibrated pulse contour cardiac output monitorGoal directed volume therapy using stroke volume variation and cardiac output to guide volume therapy and inotropic support. | Device | advanced hemodynamic monitoring |
Primary outcome
HLA-DR Expression on monocytes after surgery
Time frame: 24 hours
1 secondary outcome
ICU stay
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
Related trials for Postoperative Wound Infection
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
Not yet recruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
Surgical Site Infection, Skin Cancer
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.
Michael Sander, MD principal investigator
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Claudia Spies, MD study chair
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse contour cardiac output device in people with Postoperative Wound Infection and Postoperative Outcome, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Sander, MD (+49 30 450 531 ext. 012, Michael.Sander@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HLA-DR Expression on monocytes after surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2013.