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

Osteoarthritis, Hip Clinical Trial

— KEEP-HB  

Official title:

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.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00851149
• Other study ID #: 6.2009.36
• Status: Unknown status
• Phase: N/A
• First received: February 23, 2009
• Last updated: June 10, 2010
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)?

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a2-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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Diseases
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Sangvia blood sampling system
Blood collected from abdominal aortic repair patients are compared against blood collected from total hip replacement patients

Locations

Country	Name	City	State
Norway	Sykehuset i Vestfold HF	Tonsberg

Sponsors (3)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	Dentsply Sirona Implants, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pro-inflammatory cytokines (IL-6, IL-8 and TNF-a) and complement activation (C3a) in blood samples collected from surgery field. Comparison between the 2 groups.		30 days
Secondary	Haemoglobin, Trc, INR in blood samples and plasma will be analysed and compared between the 2 groups.		30 days