Acute Kidney InjuryPrevenAKINCT02583945
Prevention of Postoperative Acute Kidney Injury
A study testing kidney treatment bundle (KDIGO) in people with Acute Kidney Injury, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A protocol for the improvement of the hemodynamic situation and a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- kidney treatment bundle (KDIGO)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Oct 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 65 years
- chronic kidney disease
- diabetes mellitus, chronic heart, lung or liver disease
- hemodynamic instability (intra and/or post-operative)
- trauma, burn injury, major surgery, usage of x-ray contrast and sepsis.
Who cannot join
- Age < 18 years
- pregnancy
- kidney graft recipient
- chronic renal disease with or without renal replacement therapy and cardiac surgery.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Wuerzburg, Dep. of Anesthesiology
Würzburg, 97080
About this study
Official title: Effect of a Kidney Bundle on the Occurence of Postoperative Acute Kidney Injury in Patients at Risk
Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A protocol for the improvement of the hemodynamic situation and a standardized proceeding in hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI in patients at risk after non-cardiac surgery.
Read the detailed description
All patients included in the study will be treated with the KDIGO-bundle (hemodynamic stabilization, avoidance of nephrotoxic substances, normoglycemia and measurement of creatinine in serum and urine output). 12 h, 24h as well as on day 2, 3, 5 and 10 after admission on ICU the occurence of AKI (according to KDIGO) will be assessed.
- Conditions
- Acute Kidney Injury
- Being tested
- kidney treatment bundle (KDIGO)
- Keywords
- acute kidney injury, hemodynamic stabilisation, nephrotoxic medication
- 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.
kidney treatment bundle (KDIGO)Procedure or surgery
Application of the measures of the kidney treatment bundle.
| Study group | Role | What they receive |
|---|---|---|
| kidney treatment bundle (KDIGO) | Experimental | Consequent postoperative application of a kidney treatment bundle: Protocol based hemodynamic optimization and monitoring, regular screening of creatinine in serum and of urine output, no use of potential nephrotoxic medication and normoglycemia. Receives: Procedure: kidney treatment bundle (KDIGO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative AKI
AKI according to KDIGO definition
Measured: until day 5 after surgery
Secondary outcomes (8)
Intensive care unit mortality
Measured: 28 days and 90 days after surgery
hospital mortality
Measured: up to 100 days after surgery
usage of renal replacement therapy (hours)
Measured: up to 30 days after surgery
length of invasive respirator therapy (hours)
Measured: up to 30 days after surgery
creatinine in serum
Measured: 12 hours, day 2, 3, 5 and 10 after surgery
urine output (total ml)
Measured: after 12 hours, on day 2 (in 24hour), 3 (in 24hour), 5 (in 24hour) and 10 (in 24hour) after surgery
length of hospital stay
Measured: up to 100 days after surgery
length of ICU stay
Measured: up to 100 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: Study medication without approval and stop of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Christian Wunder, Wuerzburg University Hospital
- Investigators
- Christian Wunder, MD, Principal investigator, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583945
- Sponsor's protocol ID
- 022015
- Acronym
- PrevenAKI
- Status last verified
- May 2018
- First submitted
- 23 Sep 2015
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Kidney Bundle on the Occurence of Postoperative Acute Kidney Injury in Patients at Risk
- ClinicalTrials.gov ID
- NCT02583945
- Acronym / sponsor ID
- PrevenAKI / 022015
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, hemodynamic stabilisation, nephrotoxic medication
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study medication without approval and stop of financial support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 22 Oct 2015 (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.
Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A protocol for the improvement of the hemodynamic situation and a standardized proceeding in hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI in patients at risk after non-cardiac surgery.
Detailed description
All patients included in the study will be treated with the KDIGO-bundle (hemodynamic stabilization, avoidance of nephrotoxic substances, normoglycemia and measurement of creatinine in serum and urine output). 12 h, 24h as well as on day 2, 3, 5 and 10 after admission on ICU the occurence of AKI (according to KDIGO) will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kidney treatment bundle (KDIGO) | Experimental | Procedure: kidney treatment bundle (KDIGO)Consequent postoperative application of a kidney treatment bundle: Protocol based hemodynamic optimization and monitoring, regular screening of creatinine in serum and of urine output, no use of potential nephrotoxic medication and normoglycemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 65 years
- chronic kidney disease
- diabetes mellitus, chronic heart, lung or liver disease
- hemodynamic instability (intra and/or post-operative)
- trauma, burn injury, major surgery, usage of x-ray contrast and sepsis.
Key exclusion criteria (4 listed)
- Age < 18 years
- pregnancy
- kidney graft recipient
- chronic renal disease with or without renal replacement therapy and cardiac surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kidney treatment bundle (KDIGO)Application of the measures of the kidney treatment bundle. | Procedure or surgery | kidney treatment bundle (KDIGO) |
Primary outcome
Incidence of postoperative AKI
Time frame: until day 5 after surgery
AKI according to KDIGO definition
8 secondary outcomes
Intensive care unit mortality
Time frame: 28 days and 90 days after surgery
hospital mortality
Time frame: up to 100 days after surgery
usage of renal replacement therapy (hours)
Time frame: up to 30 days after surgery
length of invasive respirator therapy (hours)
Time frame: up to 30 days after surgery
creatinine in serum
Time frame: 12 hours, day 2, 3, 5 and 10 after surgery
urine output (total ml)
Time frame: after 12 hours, on day 2 (in 24hour), 3 (in 24hour), 5 (in 24hour) and 10 (in 24hour) after surgery
length of hospital stay
Time frame: up to 100 days after surgery
length of ICU stay
Time frame: up to 100 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
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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.
Christian Wunder, MD principal investigator
University of Wuerzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kidney treatment bundle (KDIGO) in people with Acute Kidney Injury, run by Wuerzburg University Hospital 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 1 Jun 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of postoperative AKI (time frame: until day 5 after surgery). 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 1 Jun 2018.