Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr R K Vohra


Contact details

Vascular Surgery
Selly Oak Hospital
B29 6JD
United Kingdom
+44 (0)121 627 1627

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Metabolic Substrate Support and Tight Glycaemic control in Abdominal Aortic Aneurysm (AAA) Repair


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Surgery: Abdominal aortic aneurysm (AAA) repair


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



Not Applicable

Drug names


Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Selly Oak Hospital
B29 6JD
United Kingdom

Sponsor information


Department of Health

Sponsor details

Richmond House
79 Whitehall
United Kingdom

Sponsor type




Funder type


Funder name

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes