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Clinical Trials/NCT01184430
NCT01184430
Unknown
Not Applicable

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

Charite University, Berlin, Germany1 site in 1 country40 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Wound Infection
Sponsor
Charite University, Berlin, Germany
Enrollment
40
Locations
1
Primary Endpoint
HLA-DR Expression on monocytes after surgery
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
December 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Sander

Vice Chair

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

HLA-DR Expression on monocytes after surgery

Time Frame: 24 hours

Secondary Outcomes

  • ICU stay(24 hours)

Study Sites (1)

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