Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/05/2013
Date assigned
14/06/2013
Last edited
14/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Jan Poelaert

ORCID ID

Contact details

UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium

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 measures

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

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

http://www.uzbrussel.be

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes