Contact information
Type
Scientific
Primary contact
Mr R K Vohra
ORCID ID
Contact details
Vascular Surgery
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
+44 (0)121 627 1627
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265126499
Study information
Scientific title
Metabolic Substrate Support and Tight Glycaemic control in Abdominal Aortic Aneurysm (AAA) Repair
Acronym
Study hypothesis
It is hypothesised that glucose-insulin-potassium (GIK) solution will reduce the incidence of perioperative myocardial ischaemia and attenuate the inflammatory response associated with AAA repair. It is further hypothesised that there will be a proportion of patients undergoing abdominal non vascular surgery in which there is cardiac and skeletal muscle damage and systemic inflammation detected. This proportion is however hypothesised to be less than in AAA repair.
Ethics approval
Not provided at time of registration
Study design
Randomised 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 the contact details below to request a patient information sheet
Condition
Surgery: Abdominal aortic aneurysm (AAA) repair
Intervention
Patients are randomised to receive either glucose-insulin-potassium or ALK or normal saline solution.
Specimen collection in Theatre. Selly Oak Hospital Intensive Therapy Unit (ITU) and on Selly Oak Hospital Vascular Ward. Blood (10 ml) and urine (5 ml from catheter bag) samples will be collected pre-operatively, during the procedure and at intervals up to 3 days postoperatively. In total, 5 sets of blood and 8 sets of urine specimens will be collected per patient. Blood will be collected from an arterial line or central line and will rarely involve additional venepuncture. Cardiac and inflammatory markers measured on these samples will include cardiac Troponin I, total Creatine Kinase (CK), CK myocardial band (CK-MB) fraction, C-reactive protein (CRP), interleukin 6 (IL6) and urinary microalbumin.
In addition, hourly monitoring of arterial blood gases, glucose, lactate and potassium will be taken from commencement of study solution until 6 hours following completion of study solution infusion. This will involve 15 x ml blood samples taken painlessly from an arterial line and ensures the safety of the study.
Femoral Venous Blood Sampling in Theatre and Selly Oak Hospital ITU
Blood (5 ml) will be collected before surgery, during surgery and up to 24 hours following surgery. In total 5 sets of specimens will be collected per patient. This is a technique of blood taking that is widely employed by medical staff in hospitals when patients have poor arm veins for phlebotomy. Risks of the procedure are as for normal blood taking, i.e. a bruise.
Gastric tonometry
After induction of anaesthesia, a gastric tonometer will be inserted by the surgical research fellow to monitor the splanchnic perfusion. This is an adapted nasogastric tube which has gastric pH monitoring capabilities. A nasogastric tube is normally placed in all patients undergoing AAA repair.
Intervention type
Drug
Phase
Not Applicable
Drug names
Glucose-insulin-potassium
Primary outcome measures
A reduction in cardiac Tropinin I release of 0.75 standard deviations from the mean in the GIK group compared with the control group.
Secondary outcome measures
Secondary (in GIK group) - Reduced cardiac ischaemia as measured by electrocardiogram (ECG), creatinine kinase (CK) total and CK-MB, reduced inflammatory response as measured by IL6, CRP, gastric tonometry - reduced Intensive Therapy Unit (ITU) stay, intubation time.
Overall trial start date
05/09/2003
Overall trial end date
05/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
60 patients requiring elective infra-renal aortic surgery for aneurysm disease will be recruited over 18 months in the Department of Vascular Surgery. All 60 patients will be randomised to receive the "study solution" either ALK or normal saline control.
A further group of 30 patients (age and sex matched controls) undergoing elective abdominal, non vascular surgery will also be studied. They will not have any therapeutic interventions but will be managed as per usual by the medical teams looking after them. Cardiac and skeletal muscle damage and systemic inflammation will be measured in these patients for up to 5 days post operatively.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Pregnancy
2. Patients <18 years old
3. Patients with Diabetes Mellitus
4. Patients who have not given informed consent
5. Patients who are unable to give informed consent
6. Patients with a preoperative haemoglobin of <11 g/dl
7. Patients undergoing emergency surgery for ruptured abdominal aortic aneurysm
8. Patients with a history of sensitivity reaction to the solutions under study
9. Patients participating in another study
10. Patients with renal impairment. creatinine >200 gmol/I
Recruitment start date
05/09/2003
Recruitment end date
05/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
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