Optimising blood-circulation and oxygen delivery in lower limb arterial surgery
| ISRCTN | ISRCTN02694138 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02694138 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/01/2011
- Registration date
- 24/02/2011
- Last edited
- 24/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Palle Toft
Scientific
Scientific
Dept. of Anaesthesia and Intensive Care
Odense University Hospital
Odense
5000
Denmark
| palle.toft@ouh.regionsyddanmark.dk |
Study information
| Study design | Prospective randomised partly blinded controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Haemodynamic optimisation in elective lower limb arterial surgery: a prospective randomised partly blinded controlled trial |
| Study objectives | Elective lower limb arterial surgery is performed in patients with critical ischaemia due to atherosclerosis. These patients often have severe co-morbidity and are at high risk of post-operative complications. Maintaining optimal circulation is important during and after surgery in patients with general atherosclerotic disease. Precise and individual circulatory therapy can be performed by continuously monitoring and optimising the patient's stroke volume and oxygen delivery during and after surgery. Optimisation is performed by giving colloid boluses to achieve the individual optimal stroke volume intra-operatively, supplemented by infusion of dobutamine post-operatively to maintain delivery of oxygen above 600 ml/min/m2. This protocol may reduce post-operative complications and death, as well as length of stay in the hospital. |
| Ethics approval(s) | The Local Medical Ethics Committee (Den Videnskabsetiske Komite for Region Syddanmark) approved in June 2008 (ref: S-20080056) |
| Health condition(s) or problem(s) studied | Primary elective lower limb arterial surgery |
| Intervention | 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 Lithium Dilution Cardiac Output (LiDCO)-plus-system was established and calibrated at arrival to the operating theatre. The intervention period ended 6 hours post-operatively. Patients were followed for 30 days post-operatively. Establishment and calibration of the LiDCO-plus-system were carried out by a member of the research team who had no involvement in the peri- and post-operative care and decision making. This allowed complete blinding of both surgical, anaesthetic and Post Anaesthetic Care Unit (PACU) clinical teams to LiDCO-plus-system readings in the control group. All anaesthetic interventions were at the discretion of the anaesthetist responsible for the peri-operative management of the patient. All patients were fasting over night and no pre-operative intravenous fluids were given. Patients received general anaesthesia with fentanyl, thiopental, rocuronium and sevoflurane in oxygen/air or spinal anaesthesia with bupivacain 0.5% spinal solution. In all patients an epidural catheter was inserted at the L3-L4 level and an epidural infusion of bupivacain with fentanyl was initiated before start of surgery or after two hours, if spinal anaesthesia was used and continued until postoperative day 2 or 3. Standard monitoring for both groups included continuous pulse oxymetri, electrocardiography, invasive arterial and central venous blood pressure monitoring, and spirometry with inspiratory and expiratory oxygen, carbon dioxide and anaesthetic gas monitoring. Arterial blood gases were analysed at predefined points in both groups. Stroke volume index (SVI), cardiac index (CI) and oxygen delivery index (DO2I) were continuously monitored, by lithium indicator dilution and pulse power analysis using the LiDCO-plus-system in all patients, but data was blinded in the control group. All patients were treated to achieve a heart rate less than 100 bpm or less than 20% above baseline, a mean arterial pressure (MAP) between 60 - 100 mgHg, a central venous pressure (CVP) between 4 - 16, body temperature greater than 36.5°C, an arterial oxygen saturation (SaO2) greater than 94%, a haemoglobin concentration greater than 6 mmol/l, and an urine output greater than 0.5 - 1.0 ml/min/kg in the post-operative period. In all patients crystalloid, colloid, blood products and vasopressors were administered in the peri-and post-operative periods by the anaesthetist based on intra- and post-operative losses, standard haemodynamic parameters and blood-gases. Intervention: Patients in the intervention group received 250 ml boluses of intravenous colloid solution (Voluven®, Fresenius Kabi AB, Upsala, Sweden) to achieve a sustained rise in SVI of at least 10% for 20 minutes in the peri- and post-operative period. Fluid boluses of Voluven® were repeated if SV subsequently decreased or if there was clinical suspicion of hypovolaemia. Furthermore, in the post-operative period, the IGDT group received dobutamine up to a maximum of 10 µg/kg/min if DO2I did not reach 600 ml/min/m2 with intravenous fluid alone. During infusion of dobutamine, monitoring was supplemented with 5-lead-electrocardiography, and at signs of myocardial ischaemia or heart rate greater than 100 minutes or greater than 20% above baseline, infusion was reduced or discontinued. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/06/2008 |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Patients scheduled for primary elective lower limb arterial surgery 2. Informed consent 3. Aged 46 - 90 years, either sex |
| Key exclusion criteria | 1. End stage renal failure 2. Lithium therapy 3. Body weight less than 40 kg (88.18 lbs) |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Dept. of Anaesthesia and Intensive Care
Odense
5000
Denmark
5000
Denmark
Sponsor information
Lillebaelt Hospital Kolding (Denmark)
Hospital/treatment centre
Hospital/treatment centre
Department of Anaesthesia and Intensive Care
Skovvangen 2-8
Kolding
DK6100
Denmark
Funders
Funder type
Hospital/treatment centre
Lillebaelt Hospital Kolding (Denmark) - Local research fund
No information available
The Toyota Fund (Denmark)
No information available
Research Initiative of The Danish Society of Anaesthesiology and Intensive Care Medicine (Denmark)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
