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

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ClinicalTrials.gov Identifier: NCT00426192
Recruitment Status : Unknown
Verified January 2007 by University Hospital, Saarland.
Recruitment status was:  Active, not recruiting
First Posted : January 24, 2007
Last Update Posted : January 24, 2007
Sponsor:
Collaborator:
Else Kröner Fresenius Foundation
Information provided by:
University Hospital, Saarland

Brief Summary:
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 or disease Intervention/treatment Phase
Inflammation Drug: i.v. mannitol Procedure: hemofiltration Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 52 participants
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
Study Start Date : October 2003
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol
U.S. FDA Resources




Primary Outcome Measures :
  1. LPS-stimulated cytokine release
  2. LPS-stimulated CD14 exppression density


Information from the National Library of Medicine

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

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

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


Locations
Germany
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
Investigators
Principal Investigator: Hauke Rensing, MD PhD University of Saarland

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

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

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