Plain English Summary
Background and study aims
Though acute kidney injury (AKI) [kidneys suddenly (acute) become unable to do the work expected of them] is extremely common, the knowledge about this disease in the perioperative phase (at or around the time of operation) is very poor. This study aims to understand the interfering factors and predictors of renal function in the perioperative setting (within 48 h postoperatively) after moderate to high-risk surgery in both patients with normal or already preoperatively compromised renal function. Independent predictor for acute kidney injury (AKI) and incidence of AKI in the perioperative setting will be determined. Finally, different types of surgery will be assessed and the relationship between occurrence of AKI and the type of surgery will be assessed. The findings of this study will be used in the improvement and quality program in University Hospital Brussels.
Who can participate?
All patients who underwent a moderate to high-risk surgery in one year will be included in this study.
What does the study involve?
Preoperative and postoperative renal function data, mortality after 30 days after surgery and length of stay in the hospital will be assessed. The association between preoperative patient characteristics and AKI will be assessed. Independent risk factors to develop AKI and on mortality will be determined. Finally, those patients with chronic kidney disease will be analysed separately to determine independent predictors to develop worsening kidney function.
What are the possible benefits and risks of participating?
As this is an observational study, there is no risk.
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 June 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 and outcome of perioperative renal failure after moderate and severe surgery
Acronym
Study hypothesis
Retrospectively, incidence of perioperative renal failure in moderate or high risk surgical procedures will be assessed, in addition in those patients with diminished renal function, postoperative renal failure will noted and registered.
Ethics approval
Ethics Committee University Hospital Brussels, Approval date: 22/12/2011, ref: 2011/282
Study design
Retrospective observational study
Primary study design
Observational
Secondary study design
Other
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
Renal failure, postoperative outcome
Intervention
The observational study concerns the occurrence rate of renal failure preoperatively and postoperatively. The purpose is to come to a risk score in our hospital. Therefore we need a large population (we deliberately took one year of patients) and variables such as preoperative status (cardiac, respiratory, renal) as well as the same variables on postoperative day (POD) 1 and 30 day mortality and length of stay in the hospital.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
30 day mortality
Secondary outcome measures
1. Renal function at discharge. The renal function will be assessed according to the RIFLE criteria:
Risk: increase of the serum creatinine x1.5GFR or drop down >25%
Injury: increase of the serum creatinine x2GFR or drop down >50%
Failure: increase of the serum creatininex3 GFR or drop down >75%
Loss: total loss of kidney function for more than 4 weeks
ESDR: complete loss of kidney function, need for dialysis
2. Need for postoperative supportive measures
Overall trial start date
01/06/2013
Overall trial end date
01/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients ≥18 years male/female, who have had in 2010/2011 a moderate to high risk surgery
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 the investigation year 2010/2011
Participant exclusion criteria
1. Absence of moderate or high risk surgery
2. < 18 years and kidney transplant recipients
3. Surgery under local anesthesia
4. Patients in which no serum creatinine determination pre-and postoperative was done
5. Patients who already have preoperative end-stage renal disease (ESRD) according to the RIFLE criteria
Recruitment start date
01/06/2013
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