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
Scientific
Vascular Surgery
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
| Phone | +44 (0)121 627 1627 |
|---|---|
| abc@email.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Metabolic Substrate Support and Tight Glycaemic control in Abdominal Aortic Aneurysm (AAA) Repair |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Glucose-insulin-potassium |
| 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 study start date | 05/09/2003 |
| Completion date | 05/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 05/09/2003 |
| Date of final enrolment | 05/09/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Department of Health
Government
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 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 |
