Incidence of postoperative complications in diabetes or hyperglycaemia
| ISRCTN | ISRCTN91071629 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91071629 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/05/2013
- Registration date
- 14/06/2013
- Last edited
- 14/06/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Hyperglycaemia (high blood sugar) may interfere with many biological processes in a recovering surgical patient. In particular in the perioperative phase (at or around the time of operation), some research points towards a strong link on inflammation, renal failure and even cardiac problems in those patients with severely increased glycaemia levels. The aim of the study is to assess in patients undergoing intermediate or high risk surgery the occurrence rate of disturbed glycaemia and to study the effects on outcome variables such as mortality, length of stay in the hospital, infection rate and occurrence of acute kidney injury. These findings will help set up a quality improvement program in our hospital settings.
Who can participate?
All surgical patients who underwent moderate to high-risk surgery in 2011, will be included.
What does the study involve?
Glycaemia preoperatively and on day of surgery, as well as up to 7 days postoperatively will be assessed. Other variables like haemoglobin and creatinine will also be noted in the same way. Also, presence of infection based on clinical symptoms and C-reactive protein (CRP) increase postoperatively (an inflammatory indicator which is also related to occurrence of infection), development of acute renal failure, 30-day mortality, total mortality and finally length of stay in the hospital will be assessed.
What are the possible benefits and risks of participating?
As this is an observational study there is no risk involved.
Where is the study run from?
The study is run from the University Hospital, department of Anesthesiology and Perioperative Medicine in Brussels.
When is the study starting and how long is it expected to run for?
The study started in April 2013 and is expected to last till September 2013.
Who is funding the study?
University Hospital Brussels (Belgium) - Department of Anaesthesiology and Perioperative Medicine
Who is the main contact?
Jan Poelaert, MD, PhD
University Hospital Brussels
Contact information
Scientific
UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium
Study information
| Study design | Retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No patient information sheet, as this study is retrospective and observational. The ethics committee waived the use of a patient information sheet. |
| Scientific title | Incidence of postoperative complications in diabetes or hyperglycaemia: a retrospective observational study |
| Study objectives | Assessment of postoperative complications in diabetes or hyperglycaemic patients such as prolonged length of stay in the hospital, infections, renal failure and 30-day mortality. |
| Ethics approval(s) | Ethics Committee UZ Brussel, Approval date: 26/03/2013, ref: 2013/068 |
| Health condition(s) or problem(s) studied | Diabetes Mellitus, Hyperglycaemia, postoperative |
| Intervention | Variables to be included are glycaemia preoperatively and on day of surgery, postoperative day (POD) 2 and 3, as well as up to 7 days postoperatively (POD 7). Other variables will also be noted in the same way: haemoglobin, creatinine, and C-reactive protein (CRP). Also, presence of infection, based on clinical symptoms and CRP increase postoperatively, 30-day mortality and total mortality and finally length of stay in the hospital will be assessed. |
| Intervention type | Other |
| Primary outcome measure | 30-day mortality |
| Secondary outcome measures | 1. Infections 2. Renal failure 3. Length of stay in the hospital |
| Overall study start date | 01/04/2013 |
| Completion date | 01/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | The number is not fixed and depends completely on the surgical activity in that particular investigation year 2011. |
| Key inclusion criteria | All patients (18-85 years) undergoing non-cardiac surgery in 2012 Diabetes patients, hyperglycaemic patients, with normalization of glycaemia after the stress period of the surgery and normoglycaemic patients. |
| Key exclusion criteria | 1. Local regional anesthesia 2. Cardiac surgery |
| Date of first enrolment | 01/04/2013 |
| Date of final enrolment | 01/09/2013 |
Locations
Countries of recruitment
- Belgium
Study participating centre
1090
Belgium
Sponsor information
Hospital/treatment centre
Department of Anaesthesiology and Perioperative Medicine
Laarbeeklaan 101
Brussels
1090
Belgium
| Website | http://www.uzbrussel.be |
|---|---|
"ROR" |
https://ror.org/038f7y939 |
Funders
Funder type
Hospital/treatment centre
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 |
