Acute Kidney InjuryPhase 4NCT02499185
Study Evaluating Novel Biomarkers of AKI (Acute Kidney Injury) in Post-operative Patients
A Phase 4 study testing Nephro Check Test and serum creatinine measurement in people with Acute Kidney Injury and Arterial Hypertension, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
To validate the use of [TIMP-2]●[IGFBP-7] to predict AKI in patients undergoing major intra abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Arterial Hypertension, Obesity
- What is being tested?
- Nephro Check Test and serum creatinine measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2015to 31 Aug 2017
- Phase
- Phase 4
- 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
- ≥ 18 years
- High risk patients: General Surgery AKI Risk Index Class III, IV or V
- Major abdominal surgery
Who cannot join
- Ongoing acute kidney injury Stage 2/3
- History of kidney transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PILOT Study Evaluating Novel Biomarkers of AKI in Post-operative Patients Undergoing Major Intra-Abdominal Surgery
To validate the use of [TIMP-2]●[IGFBP-7] to predict AKI in patients undergoing major intra abdominal surgery.
Read the detailed description
A prospective pilot single center study to investigate the potential of [TIMP-2].[IGFBP-7] to predict AKI (Acute Kidney Injury) in patients undergoing major abdominal surgery. The investigators will measure the biomarker once preoperatively and 4-times postoperatively starting at arrival on PACU (post anesthesia care unit).The primary endpoint of this study is the development of AKI stage 2 or 3 within the first 72 postoperative hours.
- Conditions
- Acute Kidney Injury, Arterial Hypertension, Obesity, Cardio Vascular Disease, Diabetes Mellitus, Chronic Liver Disease
- Being tested
- Nephro Check Test, serum creatinine measurement
- Keywords
- Biomarker, Intra Abdominal Surgery, AKI
- Medical subject headings
- Acute Kidney Injury, Hypertension, Obesity, Diabetes Mellitus, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nephro Check TestDevice
Urine sample
serum creatinine measurementOther
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| Nephro Check Test | Experimental | We take urine samples and analyse the level of [TIMP-2]●[IGFBP-7] using the NephroCheck Test to diagnose AKI Receives: Device: Nephro Check Test; Other: serum creatinine measurement |
| serum creatinine measurement | Active comparator | This is the "Golden standard" to diagnose AKI Receives: Device: Nephro Check Test; Other: serum creatinine measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines
Measured: 72 Hours
Secondary outcomes (1)
Number of participants who need renal replacement therapy
the need renal replacement therapy wil be evaluated by the nephrologist (acid base disturbances, hypervolemia,...)
Measured: 30 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 start1 Apr 2015
- Primary completion31 Jul 2017
- Study completion31 Aug 2017
Why it stopped: No patients with renal failure
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.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Lien Torisaen, MD, Principal investigator, Universitair Ziekenhuis BrusselJan Poelaert, Prof.Dr., Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499185
- Sponsor's protocol ID
- NOVELBIO
- Status last verified
- Oct 2016
- First submitted
- 30 Jun 2015
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PILOT Study Evaluating Novel Biomarkers of AKI in Post-operative Patients Undergoing Major Intra-Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02499185
- Acronym / sponsor ID
- NOVELBIO
- Conditions
- Acute Kidney Injury, Arterial Hypertension, Obesity, Cardio Vascular Disease, Diabetes Mellitus, Chronic Liver Disease
- Keywords
- Biomarker, Intra Abdominal Surgery, AKI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No patients with renal failure
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Aug 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.
To validate the use of [TIMP-2]●[IGFBP-7] to predict AKI in patients undergoing major intra abdominal surgery.
Detailed description
A prospective pilot single center study to investigate the potential of [TIMP-2].[IGFBP-7] to predict AKI (Acute Kidney Injury) in patients undergoing major abdominal surgery. The investigators will measure the biomarker once preoperatively and 4-times postoperatively starting at arrival on PACU (post anesthesia care unit).The primary endpoint of this study is the development of AKI stage 2 or 3 within the first 72 postoperative hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nephro Check Test | Experimental | Device: Nephro Check Test, Other: serum creatinine measurementWe take urine samples and analyse the level of [TIMP-2]●[IGFBP-7] using the NephroCheck Test to diagnose AKI |
| serum creatinine measurement | Active comparator | Device: Nephro Check Test, Other: serum creatinine measurementThis is the "Golden standard" to diagnose AKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years
- High risk patients: General Surgery AKI Risk Index Class III, IV or V
- Major abdominal surgery
Key exclusion criteria (2 listed)
- Ongoing acute kidney injury Stage 2/3
- History of kidney transplant
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 |
|---|---|---|
| Nephro Check TestUrine sample | Device | Nephro Check Test, serum creatinine measurement |
| serum creatinine measurementBlood sample | Other | Nephro Check Test, serum creatinine measurement |
Primary outcome
Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines
Time frame: 72 Hours
1 secondary outcome
Number of participants who need renal replacement therapy
Time frame: 30 Days
Results and safety
The study was stopped early (reason given: No patients with renal failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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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.
Lien Torisaen, MD principal investigator
Universitair Ziekenhuis Brussel
Jan Poelaert, Prof.Dr. study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nephro Check Test and serum creatinine measurement in people with Acute Kidney Injury and Arterial Hypertension, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 2 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: stopped early, as of the sponsor's last update on 15 Oct 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No patients with renal failure). Results are not available in the source record.
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?
Number of participants diagnosed with AKI stage 2 or 3 using the updated rifle "KDIGO" guidelines (time frame: 72 Hours). 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 15 Oct 2018.