Optimising blood-circulation and oxygen delivery in planned abdominal aortic surgery
| ISRCTN | ISRCTN24645910 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24645910 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/08/2010
- Registration date
- 03/09/2010
- Last edited
- 13/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Palle Toft
Scientific
Scientific
Department of Anaesthesiology and Intensive Care
Odense University Hospital
Sdr. Boulevard 29
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 | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Optimising stroke volume and oxygen delivery in elective abdominal aortic surgery: a randomised controlled trial |
| Study objectives | Elective abdominal aortic surgery is performed in patients with aneurism or occlusive atherosclerotic disease. These patients often have severe co-morbidity and are at high risk of postoperative complications. Maintaining optimal circulation during aortic surgery is difficult due to aortic cross clamping and often profound haemorrhage in combination with anaesthetising a patient 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 intraoperatively, supplemented by infusion of Dobutamine postoperatively to maintain delivery of oxygen above 600 ml min-1 m-2 . This protocol may reduce postoperative complications and death, as well as length of stay in the Intensive Care Unit and hospital. |
| Ethics approval(s) | The Local Medical Ethics Committee (Den Videnskabsetiske Komite for Region Syddanmark) approved in June 2008 (ref: S-20080055) |
| Health condition(s) or problem(s) studied | Elective abdominal aortic surgery; Atherosclerotic abdominal aortic occlusive disease; Abdominal aortic aneurism |
| Intervention | Patients were assigned to Individual Goal Directed Therapy (IGDT) or control groups by computer-generated random sequence. The intervention period started preoperatively, 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 postoperatively. Patients were followed for 30 days postoperatively. 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 postoperative 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 perioperative management of the patient. All patients received general anaesthesia with fentanyl, thiopental, rocuronium and sevoflurane in oxygen/air. Before induction of anaesthesia an epidural catheter was inserted at the low thoracic level and an epidural infusion of bupivacain with fentanyl was started 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, carbondioxide 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 < 100 bpm or <20% above baseline, a mean arterial pressure (MAP) between 60-100 mgHg, a central venous pressure (CVP) between 4-16, body temperature > 36,5°C, an arterial oxygen saturation (SaO2) > 94%, a haemoglobin concentration > 6 mmol l-1, and an urine output > 0.5-1.0 ml min-1 kg-1 in the postoperative period. In all patients crystalloid, colloid, blood products and vasopressors were administered in the peri-and postoperative periods by the anaesthetist based on intra- and postoperative losses, standard haemodynamic parameters and blood-gases. Intervention: Patients in the IGDT group in the peri- and postoperative period 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 min. Fluid boluses of Voluven® were repeated if SV subsequently decreased or if there was clinical suspicion of hypovolaemia. Furthermore, in the postoperative period, the IGDT group received dobutamine up to a maximum of 10 ug kg-1 min-1 if DO2I did not reach 600 ml min-1 m-2 with intravenous fluid alone. During infusion of dobutamine, monitoring was supplemented with 5-lead-electrocardiography, and at signs of myocardiel ischemia or heart rate > 100 min-1 or > 20% above baseline, infusion was reduced or discontinued. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | One or more severe postoperative complications: 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) > 5000 22. Reoperation 23. Readmission to ICU 24. Need of respirator 25. Need of hemodialysis 26. Dead |
| Secondary outcome measures | 1. Flow-related haemodynamic parameters (SVI and Do2I) measured by the LiDCO-plus-system (LiDCO Ltd., Cambridge, UK) 2. Length of stay in Intensive Care Unit 3. Length of hospital stay |
| Overall study start date | 01/06/2008 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 85 |
| Key inclusion criteria | Consecutive patients admitted for elective abdominal aortic surgery |
| Key exclusion criteria | 1. Chronic renal end-failure 2. Preoperative Lithium therapy 3. Body weight < 40 Kg (88,18 lbs) |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Department of Anaesthesiology and Intensive Care
Odense
5000
Denmark
5000
Denmark
Sponsor information
Department of Anaesthesiology Kolding (Denmark)
Hospital/treatment centre
Hospital/treatment centre
Lillebaelt Hospital Kolding
Skovvangen 2-8
Kolding
6000
Denmark
| Phone | +45 7636 2000 |
|---|---|
| jannie.bisgaard@slb.regionsyddanmark.dk | |
"ROR" |
https://ror.org/037y5zq83 |
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 01/01/2010 | Yes | No | ||
| Results article | 01/02/2013 | Yes | No |
Editorial Notes
HF 13/09/2017: corrected pub stage.
