NCT00426192

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
Last Updated

January 24, 2007

Status Verified

January 1, 2007

First QC Date

January 3, 2007

Last Update Submit

January 23, 2007

Conditions

Inflammation

Keywords

Immunedefense SuppressionCardiopulmonary BypassMannitolHemofiltrationCytokinesReceptors, Surface CD14

Outcome Measures

Primary Outcomes (2)

  • LPS-stimulated cytokine release

  • LPS-stimulated CD14 exppression density

Interventions

i.v. mannitolDRUG
hemofiltrationPROCEDURE

Eligibility Criteria

Age35 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saarland, Department of Anesthesiology, Intensive Care Medicine and Pain Therapy

Homburg/Saar, Saarland, 66421, Germany

Location

Related Publications (5)

  • Wan S, LeClerc JL, Vincent JL. Inflammatory response to cardiopulmonary bypass: mechanisms involved and possible therapeutic strategies. Chest. 1997 Sep;112(3):676-92. doi: 10.1378/chest.112.3.676.

    PMID: 9315800BACKGROUND

  • Grundmann U, Rensing H, Adams HA, Falk S, Wendler O, Ebinger N, Bauer M. Endotoxin desensitization of human mononuclear cells after cardiopulmonary bypass: role of humoral factors. Anesthesiology. 2000 Aug;93(2):359-69. doi: 10.1097/00000542-200008000-00013.

    PMID: 10910482BACKGROUND

  • Wilhelm W, Grundmann U, Rensing H, Werth M, Langemeyer J, Stracke C, Dhingra D, Bauer M. Monocyte deactivation in severe human sepsis or following cardiopulmonary bypass. Shock. 2002 May;17(5):354-60. doi: 10.1097/00024382-200205000-00002.

    PMID: 12022753BACKGROUND

  • Kleinschmidt S, Wanner GA, Bussmann D, Kremer JP, Ziegenfuss T, Menger MD, Bauer M. Proinflammatory cytokine gene expression in whole blood from patients undergoing coronary artery bypass surgery and its modulation by pentoxifylline. Shock. 1998 Jan;9(1):12-20. doi: 10.1097/00024382-199801000-00002.

    PMID: 9466468BACKGROUND

  • Ziegenfuss T, Wanner GA, Grass C, Bauer I, Schuder G, Kleinschmidt S, Menger MD, Bauer M. Mixed agonistic-antagonistic cytokine response in whole blood from patients undergoing abdominal aortic aneurysm repair. Intensive Care Med. 1999 Mar;25(3):279-87. doi: 10.1007/s001340050836.

    PMID: 10229162BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Hemofiltration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Hauke Rensing, MD PhD

    University of Saarland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 24, 2007

Study Start

October 1, 2003

Study Completion

November 1, 2004

Last Updated

January 24, 2007

Record last verified: 2007-01

Locations

DE(1)