Acute Kidney InjuryBigpAKNCT02500394
Biomarker Guided Intervention for Prevention of Acute Kidney Injury
A study testing Ionosteril in people with Acute Kidney Injury, run by University Hospital Regensburg at 1 site in Germany.
Trial summary
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients. Eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care… 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?
- Ionosteril
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jan 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
None listed.
Who cannot join
- age < 18 years,
- end stage renal disease (ESRD),
- preexisting dialysis,
- withdrawal of consent,
- pregnancy,
- breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarker Guided Intervention to Prevent Development of Acute Kidney Injury in High-risk Surgical Patients
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients. Eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care group or an interventional group in which patients receive intensified volume therapy.
Read the detailed description
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.Used markers have been identified as markers of tubular stress and have been validated in previous studies with more than 1500 patients. The advantage of a biomarker guided approach is the saving of time for the diagnosis a developing acute kidney injury (AKI) in high risk surgical patients, since clinical signs of AKI (rise in creatinine/decline of estimated Glomerular Filtration Rate (eGFR), decline of diuresis). If used biomarkers are above a predefined cutoff within < 4 hours after surgery, patients are randomized in to a standard care population receiving treatment in accordance with Kidney Disease Improving Global Outcomes (KDIGO) guidelines. In the intervention population patients receive individual volume therapy (= balanced electrolyte solution (Ionosteril)) (1,25 ml/kg bw up to 5 ml/kg bw for 6 hours). Degree of volume therapy is estimated by several predifined parameters, e.g. central venous pressure (CVP).
- Conditions
- Acute Kidney Injury
- Being tested
- Ionosteril
- Keywords
- renal replacement therapy
- 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.
IonosterilProcedure or surgery
biomarker guided volume substitution with Ionosteril
| Study group | Role | What they receive |
|---|---|---|
| standard care | Placebo comparator | Patients in the standard care population receive - if biomarkers are elevated -treatment of AKI in accordance with KDIGO 2012 guidelines Receives: Procedure: Ionosteril |
| interventional care | Active comparator | Patients in the interventional population receive - if biomarkers are elevated - individualized treatment/volume substitution (balanced electrolyte solution = Ionosteril; 1,25-5 ml/kg/bw/6 hours) ) on the basis of predefined criteria Receives: Procedure: Ionosteril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AKI in both group
incidence and severity of AKI according to AKI network definition within 90 days will be monitored
Measured: 90 days
Secondary outcomes (6)
need for renal replacement therapy,
Number of participants with a need for renal replacement therapy (defined as dialysis within 90 days)
Measured: 90 days
length of ICU stay
overall length of ICU stay
Measured: 90 days
length of hospital stay
overall length of ICU stay
Measured: 90 days
ICU and hospital costs
to account for resulting costs, ICU and hospital cost of the standard care and the interventional patient population are monitored
Measured: 90 days
incidence of chronic kidney disease (CKD)
Investigators want to see if there are any differences on resulting renal function - different stages of chronic kidney disease (CKD I-V) as a consequence of the performed therapy: standard care accoring to KDIGO guidelines versus interventional care
Measured: 90 days
death
overall mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionJan 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias, Bergler, MD, University Hospital Regensburg
- Investigators
- Tobias Bergler, MD, Principal investigator, UKR-Department of NephrologyIvan Göcze, MD, Principal investigator, UKR-Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500394
- Sponsor's protocol ID
- 1476-Version 6
- Acronym
- BigpAK
- Status last verified
- May 2017
- First submitted
- 7 Jul 2015
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Guided Intervention to Prevent Development of Acute Kidney Injury in High-risk Surgical Patients
- ClinicalTrials.gov ID
- NCT02500394
- Acronym / sponsor ID
- BigpAK / 1476-Version 6
- Conditions
- Acute Kidney Injury
- Keywords
- renal replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University Hospital RegensburgUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Jul 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.
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients. Eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care group or an interventional group in which patients receive intensified volume therapy.
Detailed description
This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.Used markers have been identified as markers of tubular stress and have been validated in previous studies with more than 1500 patients. The advantage of a biomarker guided approach is the saving of time for the diagnosis a developing acute kidney injury (AKI) in high risk surgical patients, since clinical signs of AKI (rise in creatinine/decline of estimated Glomerular Filtration Rate (eGFR), decline of diuresis). If used biomarkers are above a predefined cutoff within < 4 hours after surgery, patients are randomized in to a standard care population receiving treatment in accordance with Kidney Disease Improving Global Outcomes (KDIGO) guidelines. In the intervention population patients receive individual volume therapy (= balanced electrolyte solution (Ionosteril)) (1,25 ml/kg bw up to 5 ml/kg bw for 6 hours). Degree of volume therapy is estimated by several predifined parameters, e.g. central venous pressure (CVP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | Placebo comparator | Procedure: IonosterilPatients in the standard care population receive - if biomarkers are elevated -treatment of AKI in accordance with KDIGO 2012 guidelines |
| interventional care | Active comparator | Procedure: IonosterilPatients in the interventional population receive - if biomarkers are elevated - individualized treatment/volume substitution (balanced electrolyte solution = Ionosteril; 1,25-5 ml/kg/bw/6 hours) ) on the basis of predefined criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- age < 18 years,
- end stage renal disease (ESRD),
- preexisting dialysis,
- withdrawal of consent,
- pregnancy,
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 |
|---|---|---|
| Ionosterilbiomarker guided volume substitution with Ionosteril | Procedure or surgery | interventional care, standard care |
Primary outcome
Incidence and severity of AKI in both group
Time frame: 90 days
incidence and severity of AKI according to AKI network definition within 90 days will be monitored
6 secondary outcomes
need for renal replacement therapy,
Time frame: 90 days
length of ICU stay
Time frame: 90 days
length of hospital stay
Time frame: 90 days
ICU and hospital costs
Time frame: 90 days
incidence of chronic kidney disease (CKD)
Time frame: 90 days
death
Time frame: 90 days
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 5 May 2017.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Tobias Bergler, MD principal investigator
UKR-Department of Nephrology
Ivan Göcze, MD principal investigator
UKR-Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ionosteril in people with Acute Kidney Injury, run by University Hospital Regensburg 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 0 inclusion and 6 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 5 May 2017. 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. Some participants in this study may receive a placebo. 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?
Incidence and severity of AKI in both group (time frame: 90 days). 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 5 May 2017.