- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00851149
Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair (KEEP-HB)
Pro-inflammatory Cytokines (IL-1beta,IL-6, IL-8 and TNF-α) and Complement Activation (C3a) in Blood Collected From Surgery Field From Patients Undergoing Orthopedic Surgery Compared to Patients Undergoing Abdominal Aneurysm Repair.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patient (n= 10) scheduled for total hip replacement or hemiprosthesis and patient (n=10) scheduled for abdominal aortic surgery.
Primary outcome:
Pro-inflammatory cytokines (IL-6, IL-8 and TNF-α) and complement activation (C3a) in blood samples collected from surgery field. Comparison between the 2 groups.
Secondary outcome:
Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Tonsberg, Norway, 3103
- Sykehuset i Vestfold HF
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ASA 1-4
Exclusion Criteria:
- Patient using corticosteroids, NSAIDs or Cox-II inhibitors
- Patients under 18 years
- Patients who are included in pharmaceutical studies
- Opioids-, benzodiazepines-, antiepileptic drugs-, alcohol- and α2-agonists abuse
- Pregnant and breastfeeding women
- Patients with known hypersensitivity for opioids, propofol or volatile anesthetics
- Patients with serious arrhythmias (atrial fibrillation/flutter is acceptable)
- Uncontrolled hypertension, serious psychiatric disease
- Patients with unstable angina pectoris or myocardial infarction the last month before inclusion
- Acute abdominal aortic surgery (acute dissection or rupture)
- Planned laparoscopic abdominal aortic aneurysm surgery
- Transfusion of blood products last month before surgery
- Glucocorticoid users
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1/10
Abdominal aortic surgery patients
|
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients
Other Names:
|
2/10
Total hip replacement patients
|
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pro-inflammatory cytokines (IL-6, IL-8 and TNF-α) and complement activation (C3a) in blood samples collected from surgery field. Comparison between the 2 groups.
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Espen Lindholm, Md, Sykehuset i Vestfold HF
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6.2009.36
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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