Acute Renal FailureNCT01318798
Development and Validation of an Enhanced Prediction Score for Postoperative Acute Renal Failure After Liver Resection
An observational study of Acute Renal Failure, run by University of Zurich at 1 site in Switzerland.
Trial summary
Post-operative acute renal failure is a severe post-operative complication and is associated with high mortality. The enhanced prediction score, including pre-as well as intra-operative predictors accurately predicted ARF following hepatic surgery. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Acute Renal Failure
- How many people
- 549 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We included consecutively patients undergoing any type of hepatic surgery for benign as well as malignant diseases between July first, 2002 and October 31, 2007 in a single tertiary care center (Swiss Hepato-Pancreato-Biliary (HPB) Centre, University Hospital of Zurich, Switzerland.
Who may be able to join
- > 18 years
- scheduled for liver surgery
- benign as well as malignant diseases
Who cannot join
- liver trauma
- incomplete data sets
- pre-operative chronic renal failure requiring hemodialysis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich, Departmente of Visceral and Transplantation Surgery
Zurich, 8091
About this study
Official title: Development and Validation of an Enhanced Prediction Score for Post-operative Acute Renal Failure Following Liver Resection
Post-operative acute renal failure is a severe post-operative complication and is associated with high mortality. The enhanced prediction score, including pre-as well as intra-operative predictors accurately predicted ARF following hepatic surgery. This prediction score allows early identification of patients at high risk of ARF and may support decision-making for protective kidney treatment.
Read the detailed description
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.
- Conditions
- Acute Renal Failure
- Keywords
- 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
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of an enhanced prediction score for ARF
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
Measured: within 48 hours post-operative
Secondary outcomes (2)
Decision curve analysis
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
Measured: within 48 hours post-operative
internal validation of the enhanced prediction score
internal Validation: discrimination, calibration, k-fold cross validation and bootstrapping
Measured: within 48 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ksenija Slankamenac, University of Zurich
- Investigators
- Ksenija Slankamenac, med. pract., Principal investigator, University Hospital Zurich, Visceral and Transplantation Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318798
- Sponsor's protocol ID
- StV 33-2009
- Status last verified
- Feb 2015
- First submitted
- 16 Mar 2011
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Slankamenac K, Breitenstein S, Held U, Beck-Schimmer B, Puhan MA, Clavien PA. Development and validation of a prediction score for postoperative acute renal failure following liver resection. Ann Surg. 2009 Nov;250(5):720-8. doi: 10.1097/SLA.0b013e3181bdd840.
PubMed 19809295
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Enhanced Prediction Score for Post-operative Acute Renal Failure Following Liver Resection
- ClinicalTrials.gov ID
- NCT01318798
- Acronym / sponsor ID
- StV 33-2009
- Conditions
- Acute Renal Failure
- Keywords
- Development, Pre- and intra-operative predictors, Acute renal failure, Liver Surgery, Prediction score, Validation, Clinical consequences, Decision curve analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-operative acute renal failure is a severe post-operative complication and is associated with high mortality. The enhanced prediction score, including pre-as well as intra-operative predictors accurately predicted ARF following hepatic surgery. This prediction score allows early identification of patients at high risk of ARF and may support decision-making for protective kidney treatment.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included consecutively patients undergoing any type of hepatic surgery for benign as well as malignant diseases between July first, 2002 and October 31, 2007 in a single tertiary care center (Swiss Hepato-Pancreato-Biliary (HPB) Centre, University Hospital of Zurich, Switzerland.
Key inclusion criteria (3 listed)
- > 18 years
- scheduled for liver surgery
- benign as well as malignant diseases
Key exclusion criteria (3 listed)
- liver trauma
- incomplete data sets
- pre-operative chronic renal failure requiring hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Decision curve analysis
Time frame: within 48 hours post-operative
internal validation of the enhanced prediction score
Time frame: within 48 hours post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Results publication: PubMed 19809295Slankamenac K, Breitenstein S, Held U, Beck-Schimmer B, Puhan MA, Clavien PA. Development and validation of a prediction score for postoperative acute renal failure following liver resection. Ann Surg. 2009 Nov;250(5):720-8. doi: 10.1097/SLA.0b013e3181bdd840.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ksenija Slankamenac, med. pract. principal investigator
University Hospital Zurich, Visceral and Transplantation Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Renal Failure, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of an enhanced prediction score for ARF (time frame: within 48 hours post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01318798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.