Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair

• Conditions: Osteoarthritis, Hip; Aortic Diseases
• Interventions: Device: Sangvia blood sampling system

• Registration Number: NCT00851149
• Lead Sponsor: Sykehuset i Vestfold HF

Brief Summary

The purpose of this study is to investigate the contents in blood sampled from surgery site during hip replacement compared with blood sampled from abdominal aortic surgery. Is there any difference in pro-inflammatory cytokines (IL-1beta, IL-6, IL-8 and TNF-α), complement activation (C3a)?

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 Timeline

• Study First Submitted: 2009-02-23
• Study First Submitted QC: 2009-02-23
• Study First Posted: 2009-02-25
• Study Start: 2009-11
• Primary Completion: 2010-02
• Study Completion: 2010-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1/10	Sangvia blood sampling system	Abdominal aortic surgery patients
2/10	Sangvia blood sampling system	Total hip replacement patients

Primary Outcome Measures

Name	Time	Method
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.	30 days

Secondary Outcome Measures

Name	Time	Method
Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.	30 days

Trial Locations

Locations (1)

Sykehuset i Vestfold HF; 🇳🇴 Tonsberg, Norway