Optimising blood-circulation and oxygen delivery in lower limb arterial surgery

Completed

• Conditions: Surgery; Lower limb arterial surgery; Primary elective lower limb arterial surgery

• Registration Number: ISRCTN02694138
• Lead Sponsor: illebaelt Hospital Kolding (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients scheduled for primary elective lower limb arterial surgery
2. Informed consent
3. Aged 46 - 90 years, either sex

Exclusion Criteria

1. End stage renal failure
2. Lithium therapy
3. Body weight less than 40 kg (88.18 lbs)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One or more severe post-operative complications, registered after a 30 days follow up-period: <br>1. Septic shock <br>2. Pneumonia <br>3. Superficial wound infection <br>4. Deep wound infection <br>5. Abdominal infection <br>6. Urinary tract infection <br>7. Pulmonary embolus <br>8. Acute Respiratory Distress Syndrome (ARDS) <br>9. Cardiac arrest <br>10. Acute coronary syndrome <br>11. Cardiac arrhythmia (acute treatment needed) <br>12. Pulmonary oedema <br>13. Deep venous thrombosis <br>14. Cerebral thrombosis <br>15. Cerebral haemorrhage <br>16. Lower limb paresis <br>17. Acute kidney insufficiency <br>18. Intraabdominal hypertension <br>19. Severe upper gastrointestinal bleeding <br>20. Gastrointestinal paralysis <br>21. Creatine kinase (CK) greater than 5000<br>22. Reoperation <br>23. Readmission to ICU <br>24. Need of respiratory support <br>25. Need of haemodialysis <br>26. Dead

Secondary Outcome Measures

Name	Time	Method
1. Flow-related haemodynamic parameters (SVI and Do2I) measured by the LiDCO-plus-system (LiDCO Ltd., Cambridge, UK) at baseline (T0), surgery start (T1), arterial cross-clamping (T2), end of surgery (T3) and every hour 6 hours immediately after surgery (P1 - P6)<br>2. Length of hospital stay, registered after a 30 days follow up period