Development and Validation of an Enhanced Prediction Score for Postoperative Acute Renal Failure After Liver Resection
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01318798 |
|
Recruitment Status :
Completed
First Posted : March 18, 2011
Last Update Posted : February 10, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Acute Renal Failure |
To enhance and validate an already pre-existing score accurately predicting post-operative acute renal failure (ARF) after hepatic surgery
We will enhance a pre-existing score predicting ARF based on pre-operative as well as intra-operative predictors.
Development process: we will identify the strongest predictors of ARF in a multivariable logistic regression model followed by a stepwise backward logistic regression analysis and bootstrapping.
Validation process: we will perform an internal validation by calibrating the prediction model as well as by k-fold cross validation (c statistics) and bootstrapping. Additionally, we will calculate the discrimination by the area under the curve (AUC).
Decision curve analysis: Furthermore we will perform a decision curve analysis to evaluate the clinical consequences of both prediction scores whether a patient with increased ARF risk would post-operative benefit of a treatment on the ICU.
| Study Type : | Observational |
| Actual Enrollment : | 549 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Development and Validation of an Enhanced Prediction Score for Post-operative Acute Renal Failure Following Liver Resection |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | April 2012 |
| Group/Cohort |
|---|
|
Patients with post-operative ARF
Patients developing acute renal failure (ARF) following liver surgery ARF was defined according to the RIFLE criteria as an absolute increase in serum-creatinine of more than 0.3 mg/dl above baseline, or an increase of more than 1.5 times the pre-operative baseline value within 48 hours after surgery, or a reduction of urinary output less than 0.5 ml/kg/h for at least 6 hrs. |
|
Patients without post-operative ARF
Patients with normal kidney function (without acute renal failure (ARF)) following liver surgery
|
- Development of an enhanced prediction score for ARF [ Time Frame: within 48 hours post-operative ]Development of an enhanced but still simple and easy applicable score based on pre- and extended by intra-operative risk factors to predict postoperative ARF in patients scheduled for liver resection
- Decision curve analysis [ Time Frame: within 48 hours post-operative ]Describing a decision making model by performing a decision curve analysis for clinical consequences of the enhanced prediction score and comparing it with the pre-operative prediction score
- internal validation of the enhanced prediction score [ Time Frame: within 48 hours post-operative ]internal Validation: discrimination, calibration, k-fold cross validation and bootstrapping
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- > 18 years
- scheduled for liver surgery
- benign as well as malignant diseases
Exclusion Criteria:
- liver trauma
- incomplete data sets
- pre-operative chronic renal failure requiring hemodialysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318798
| Switzerland | |
| University Hospital of Zurich, Departmente of Visceral and Transplantation Surgery | |
| Zurich, Switzerland, 8091 | |
| Principal Investigator: | Ksenija Slankamenac, med. pract. | University Hospital Zurich, Visceral and Transplantation Surgery |
Publications of Results:
| Responsible Party: | Ksenija Slankamenac, Md PhD, University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01318798 History of Changes |
| Other Study ID Numbers: |
StV 33-2009 |
| First Posted: | March 18, 2011 Key Record Dates |
| Last Update Posted: | February 10, 2015 |
| Last Verified: | February 2015 |
Keywords provided by Ksenija Slankamenac, University of Zurich:
|
Development Pre- and intra-operative predictors Acute renal failure Liver Surgery Prediction score |
Validation Clinical consequences Decision curve analysis predictors of acute renal failure after liver resection |
Additional relevant MeSH terms:
|
Renal Insufficiency Acute Kidney Injury Kidney Diseases |
Urologic Diseases Liver Extracts Hematinics |