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

ISRCTN ISRCTN00879223
DOI https://doi.org/10.1186/ISRCTN00879223
Secondary identifying numbers N0265126499
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
19/08/2015
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

Mr R K Vohra
Scientific

Vascular Surgery
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Phone +44 (0)121 627 1627
Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMetabolic Substrate Support and Tight Glycaemic control in Abdominal Aortic Aneurysm (AAA) Repair
Study objectivesIt 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Abdominal aortic aneurysm (AAA) repair
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Glucose-insulin-potassium
Primary outcome measureA 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 measuresSecondary (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 study start date05/09/2003
Completion date05/09/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria60 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.
Key exclusion criteria1. 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
Date of first enrolment05/09/2003
Date of final enrolment05/09/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

University Hospital Birmingham NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan