Condition category
Urological and Genital Diseases
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
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

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 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 measures

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

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

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