Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery

NCT01184430 | Unknown DMC

• 1 other identifier: Algebra
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Wound Infection; Postoperative Outcome

Keywords

advanced hemodynamic monitoring; goal-directed therapy; cardiac surgery; hemodynamic monitoring

Outcome Measures

Primary Outcomes (1)

• HLA-DR Expression on monocytes after surgery

  24 hours

Secondary Outcomes (1)

• ICU stay

  24 hours

Study Arms (2)

advanced hemodynamic monitoring

ACTIVE COMPARATOR

advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy

Device: Pulse contour cardiac output device

standard monitoring

NO INTERVENTION

hemodynamic monitoring based on the standard operating procedures of our clinic

Interventions

Pulse contour cardiac output device DEVICE

Goal directed volume therapy using stroke volume variation and cardiac output to guide volume therapy and inotropic support.

Also known as: Non calibrated pulse contour cardiac output monitor

advanced hemodynamic monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective cardiac surgery patient undergoing cardiopulmonary bypass
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Sander, MD

  Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

  PRINCIPAL INVESTIGATOR

• Claudia Spies, MD

  Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

  STUDY CHAIR

Central Study Contacts

Michael Sander, MD

CONTACT

+49 30 450 531; Michael.Sander@charite.de

Katharina Berger, MD

CONTACT

+49 30 450 531; Katharina.Berger@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 19, 2010
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 12, 2013

Record last verified: 2013-08

Locations

DE (1)