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Effects of Hemofiltration and Mannitol Treatment on Cardiopulmonary-Bypass Induced Immunosuppression

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by University Hospital, Saarland.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: January 24, 2007
Last Update Posted: January 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Else Kröner Fresenius Foundation
Information provided by:
University Hospital, Saarland
After cardiac surgery with cardiopulmonar bypass, the LPS-stimulated cytokine response has been previously shown to be depressed. Therefore, in this trial the hypothesis was tested, whether simple immunomodulting interventions like the i.v. adminstration of mannitol of hemofiltration during cardipulmonary bypass can attenuate this immunosuppressing effect.

Condition Intervention Phase
Inflammation Drug: i.v. mannitol Procedure: hemofiltration Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Mechanisms of Endotoxin-Tolerance of Human Monocytes After CABG-Sugery - Effects of Hemofiltration and Mannitol Treatment

Resource links provided by NLM:

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • LPS-stimulated cytokine release
  • LPS-stimulated CD14 exppression density

Estimated Enrollment: 52
Study Start Date: October 2003
Estimated Study Completion Date: November 2004
Detailed Description:

Background Cardiac surgery using cardiopulmonary bypass (CPB) causes a systemic inflammatory response. In addition to this immune response to CPB, a significant impairment of the responsiveness of peripheral blood mononuclear cells (PBMC) to further immunological stimuli has been observed. The aim of our present study was to evaluate the ability of antioxidant therapy with mannitol or hemofiltration during CPB to modulate the observed immunosuppression after CPB.

Methods With ethics committee approval, 52 patients undergoing elective CABG-surgery were prospectively enrolled and randomized into 3 groups (control, 50 g mannitol iv, hemofiltration during CPB). Blood samples were taken after induction of anesthesia (T1), 20 min after separation from CPB (T2) and 24 h postoperatively (T3). Expression density of the monocytic surface receptor CD14, HLA-DR expression and cytokine release (TNF- and IL10) after LPS-stimulation were evaluated.

Results At T2, the CD14dim cell population was maintained in both intervention groups while in the control group there was a significant decrease of this proinflammatory monocytic phenotype. At T3, all groups developed a significant shift towards the antiinflammatory CD14bright population. No significant differences regarding HLA-DR expression or cytokine release could be demonstrated.

Conclusion This study shows that the suppression of the stimulated immune response after CPB can be alleviated by iv administration of mannitol or hemofiltration. In the light of data showing that this depression of the immune response might affect the postoperative course of patients, these results could lead to an improvement of the management of patients undergoing cardiac surgery with CPB.


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male patients
  • aged 35-80
  • elective CABG surgery

Exclusion Criteria:

  • previous cardiac surgery
  • ejection fraction < 40%
  • valvular heart disease
  • myocardial infarction during the last 3 months
  • evidence of concomitant malignant or immunologic diseases
  • antecedent medication with corticosteroids or methylxanthines
  • hemoglobin < 12 g/dl
  • body mass index > 30
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426192

University of Saarland, Department of Anesthesiology, Intensive Care Medicine and Pain Therapy
Homburg/Saar, Saarland, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Else Kröner Fresenius Foundation
Principal Investigator: Hauke Rensing, MD PhD University of Saarland
  More Information

ClinicalTrials.gov Identifier: NCT00426192     History of Changes
Other Study ID Numbers: AN-01
First Submitted: January 3, 2007
First Posted: January 24, 2007
Last Update Posted: January 24, 2007
Last Verified: January 2007

Keywords provided by University Hospital, Saarland:
Immunedefense Suppression
Cardiopulmonary Bypass
Receptors, Surface CD14

Additional relevant MeSH terms:
Pathologic Processes
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs