Renal InsufficiencyNEPHRANESTNCT01522313
Influence of Perioperative Kidney Function on Postoperative Outcome
An observational study of Renal Insufficiency and Acute Kidney Injury, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study investigates the influence of perioperative changes in serum creatinine on hospital length of stay and mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Insufficiency, Acute Kidney Injury
- How many people
- 39,369 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Retrsospective analysis of electronic charts of all patients that underwent anesthesia between January 2006 - June 2012 in the Department of Anesthesiology at the Charité - University Medicine Berlin, Campus Charité Mitte und Campus Virchow Klinikum.
Who may be able to join
- all patients anesthetized between January 2006 - June 2012
Who cannot join
- end stage renal disease
- pre-anesthesiologic need of renal replacement therapy
- patients undergoing nephrectomy or kidney transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Data Analysis of the Impact of Perioperative Kidney Function on Postoperative Outcome
This study investigates the influence of perioperative changes in serum creatinine on hospital length of stay and mortality.
- Conditions
- Renal Insufficiency, Acute Kidney Injury
- Medical subject headings
- Renal Insufficiency, 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 | Data of patients anesthetized in the years 2006 to 2012 (Hospital stay: January 2006 - June 2012) will be analysed in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital length of stay
once per case
Measured: 1 year
Secondary outcomes (1)
all cause in-hospital mortality
occurrence during hospital stay
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2006
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 39,369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia D Spies, MD Prof., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522313
- Sponsor's protocol ID
- NEPHRANEST
- Acronym
- NEPHRANEST
- Status last verified
- Oct 2012
- First submitted
- 23 Jan 2012
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Analysis of the Impact of Perioperative Kidney Function on Postoperative Outcome
- ClinicalTrials.gov ID
- NCT01522313
- Acronym / sponsor ID
- NEPHRANEST / NEPHRANEST
- Conditions
- Renal Insufficiency, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39,369 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Jan 2012 (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.
This study investigates the influence of perioperative changes in serum creatinine on hospital length of stay and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Data of patients anesthetized in the years 2006 to 2012 (Hospital stay: January 2006 - June 2012) will be analysed in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrsospective analysis of electronic charts of all patients that underwent anesthesia between January 2006 - June 2012 in the Department of Anesthesiology at the Charité - University Medicine Berlin, Campus Charité Mitte und Campus Virchow Klinikum.
Key inclusion criteria (1 listed)
- all patients anesthetized between January 2006 - June 2012
Key exclusion criteria (3 listed)
- end stage renal disease
- pre-anesthesiologic need of renal replacement therapy
- patients undergoing nephrectomy or kidney transplantation
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
hospital length of stay
Time frame: 1 year
once per case
1 secondary outcome
all cause in-hospital mortality
Time frame: 1 year
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 Oct 2012.
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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.
Claudia D Spies, MD Prof. principal investigator
Charite University, Berlin, Germany
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 Renal Insufficiency and Acute Kidney Injury, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 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 Oct 2012. 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 Germany. 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?
hospital length of stay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2012.