Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Incidence of postoperative complications in diabetes or hyperglycaemia: a retrospective observational study
Acronym
Study hypothesis
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
Ethics Committee UZ Brussel, Approval date: 26/03/2013, ref: 2013/068
Study design
Retrospective observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No patient information sheet, as this study is retrospective and observational. The ethics committee waived the use of a patient information sheet.
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
30-day mortality
Secondary outcome measures
1. Infections
2. Renal failure
3. Length of stay in the hospital
Overall trial start date
01/04/2013
Overall trial end date
01/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
The number is not fixed and depends completely on the surgical activity in that particular investigation year 2011.
Participant exclusion criteria
1. Local regional anesthesia
2. Cardiac surgery
Recruitment start date
01/04/2013
Recruitment end date
01/09/2013
Locations
Countries of recruitment
Belgium
Trial participating centre
UZ Brussel
Brussels
1090
Belgium
Sponsor information
Organisation
University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium)
Sponsor details
Department of Anaesthesiology and Perioperative Medicine
Laarbeeklaan 101
Brussels
1090
Belgium
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Brussels (Belgium) - Department of Anaesthesiology and Perioperative Medicine
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
Basic results (scientific)
Publication list