NCT01267721

Brief Summary

It has been repeatedly demonstrated that cardiac surgery with the use of extracorporeal circulation elicits a systemic inflammatory response and provokes ischemia-reperfusion related oxidative stress which could further lead to the development of organ failure in critically ill patients. Perioperative levels of macrophage migration inhibitory factor (MIF) and other inflammatory mediators could be involved in adverse outcomes in cardiac surgery.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

1.9 years

First QC Date

December 22, 2010

Last Update Submit

October 7, 2014

Conditions

Heart Surgery

Keywords

heart surgery

Outcome Measures

Primary Outcomes (1)

  • Pilot study: correlation between clinical and lab parameters

    To assess the importance of the MIF ligand/receptor family in a large cohort of patients (n=100) undergoing cardiac surgery and to characterize the underlying molecular events. Possible correlation between several clinical and laboratory parameters will be analyzed. This is a pilot study to generate hints at future items to be studied in controlled trials.

    two months

Secondary Outcomes (1)

  • Secondary Outcome

    two months

Study Arms (1)

Study Group

A single group of 100 consecutive patients will undergo additional blood sampling at different time points

Procedure: Blood sampling

Interventions

Blood samplingPROCEDURE

Blood sampling at various time points. Additional 92 mL blood.

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing open heart surgery and use of heart lung device

You may qualify if:

  • more than 18 years of age
  • open heart surgery and use of heart-lung-device
  • informed consent has been obtained

You may not qualify if:

  • under 18 years of age
  • emergency cases
  • informed consent cannot be obtained
  • pregnancy or patient is breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

inflammatory markers (different)

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Steffen Rex, PD Dr. med.

    RWTH Aachen University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 28, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Last Updated

October 8, 2014

Record last verified: 2014-10

Locations

DE(1)