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

Haemodynamic optimisation in elective lower limb arterial surgery: a prospective randomised partly blinded controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN02694138

Enrollment

Registered

2011-02-24

Start date

2008-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary elective lower limb arterial surgery Surgery Lower limb arterial surgery

Interventions

Patients were assigned to Individual Goal Directed Therapy (IGDT) or control groups by computer-generated random sequence. The intervention period started pre-operatively, when monitoring with the L

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
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) 2. Length of hospital stay, registered after a 30 days follow up period	—

Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026