Condition category
Surgery
Date applied
06/01/2011
Date assigned
24/02/2011
Last edited
24/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Palle Toft

ORCID ID

Contact details

Dept. of Anaesthesia and Intensive Care
Odense University Hospital
Odense
5000
Denmark
palle.toft@ouh.regionsyddanmark.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

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

The Local Medical Ethics Committee (Den Videnskabsetiske Komite for Region Syddanmark) approved in June 2008 (ref: S-20080056)

Study design

Prospective randomised partly blinded controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2008

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

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

Recruitment start date

01/06/2008

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Denmark

Trial participating centre

Dept. of Anaesthesia and Intensive Care
Odense
5000
Denmark

Sponsor information

Organisation

Lillebaelt Hospital Kolding (Denmark)

Sponsor details

Department of Anaesthesia and Intensive Care
Skovvangen 2-8
Kolding
DK6100
Denmark

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Lillebaelt Hospital Kolding (Denmark) - Local research fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Toyota Fund (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Research Initiative of The Danish Society of Anaesthesiology and Intensive Care Medicine (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes