Incidence and outcome of perioperative renal failure
| ISRCTN | ISRCTN08839267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08839267 |
| 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
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium
Study information
| Study design | Retrospective observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| 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 and outcome of perioperative renal failure after moderate and severe surgery |
| Study objectives | 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(s) | Ethics Committee University Hospital Brussels, Approval date: 22/12/2011, ref: 2011/282 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/2013 |
| Completion date | 01/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | The number is not fixed and depends completely on the surgical activity in the investigation year 2010/2011 |
| Key inclusion criteria | All patients ≥18 years male/female, who have had in 2010/2011 a moderate to high risk surgery |
| Key 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 |
| Date of first enrolment | 01/06/2013 |
| 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 |
