Renal ImpairmentCPBNAGNCT02410642
NAG-excretion During Cardiopulmonary Bypass
An observational study of Renal Impairment, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical significance, pattern of excretion and links to perioperative factors are poorly described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Impairment
- What is being tested?
- cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 patients scheduled for complex cardiac surgery
Who may be able to join
- Expected cardiopulmonary bypass time exceeding 60 minutes
- Elective surgery
Who cannot join
- End-stage kidney disease with dialysis
- Ongoing treatment with nephrotoxic antibiotic agent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of thoracic anesthesia, Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: Effects of Cardiopulmonary Bypass on Urinary Secretion of NAG
NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical significance, pattern of excretion and links to perioperative factors are poorly described. We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary bypass, and explore possible associated variables.
Read the detailed description
The standard biomarker of AKI, serum creatinine, has poor specificity and sensitivity in the early phases of renal injury. Since the therapeutic window is likely to be in the earlier stages before renal injury is manifest, there is a need for novel diagnostic methods. In the recent years, several new biomarkers of kidney injury have been introduced. To date, none has proven outstanding regarding precision in early detection of AKI. NAG (N-acetyl-b-D-glucosaminidase) is a lysosomal enzyme with high molecular weight. Due to its size, NAG does not normally pass the glomerulus apparatus, but urine levels are elevated after tubulus damage. NAG excretion in urine is seen in AKI after cardiac surgery, exposure to nephrotoxic agents and after renal transplantation. However, its role in clinical decision-making is yet to be established.
We aim to study the excretion pattern of urinary NAG during and after cardiac surgery with cardiopulmonary bypass. Association with perioperative variables will be explored.
- Conditions
- Renal Impairment
- Being tested
- cardiopulmonary bypass
- Keywords
- cardiopulmonary bypass
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary bypassProcedure or surgery
Routine use of cardiopulmonary bypass as needed during cardiac surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary NAG secretion
Secretion pattern of NAG
Measured: 24 hours
Secondary outcomes (1)
Development of AKI (acute kidney injury) according to AKIN criteria
Development of AKI (acute kidney injury) according to AKIN criteria
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Lannemyr, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410642
- Sponsor's protocol ID
- SahlgrenskaUHThoraxLL2
- Acronym
- CPBNAG
- Status last verified
- Mar 2016
- First submitted
- 2 Apr 2015
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardiopulmonary Bypass on Urinary Secretion of NAG
- ClinicalTrials.gov ID
- NCT02410642
- Acronym / sponsor ID
- CPBNAG / SahlgrenskaUHThoraxLL2
- Conditions
- Renal Impairment
- Keywords
- cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Apr 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.
NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical significance, pattern of excretion and links to perioperative factors are poorly described. We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary bypass, and explore possible associated variables.
Detailed description
The standard biomarker of AKI, serum creatinine, has poor specificity and sensitivity in the early phases of renal injury. Since the therapeutic window is likely to be in the earlier stages before renal injury is manifest, there is a need for novel diagnostic methods. In the recent years, several new biomarkers of kidney injury have been introduced. To date, none has proven outstanding regarding precision in early detection of AKI. NAG (N-acetyl-b-D-glucosaminidase) is a lysosomal enzyme with high molecular weight. Due to its size, NAG does not normally pass the glomerulus apparatus, but urine levels are elevated after tubulus damage. NAG excretion in urine is seen in AKI after cardiac surgery, exposure to nephrotoxic agents and after renal transplantation. However, its role in clinical decision-making is yet to be established.
We aim to study the excretion pattern of urinary NAG during and after cardiac surgery with cardiopulmonary bypass. Association with perioperative variables will be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients scheduled for complex cardiac surgery
Key inclusion criteria (2 listed)
- Expected cardiopulmonary bypass time exceeding 60 minutes
- Elective surgery
Key exclusion criteria (2 listed)
- End-stage kidney disease with dialysis
- Ongoing treatment with nephrotoxic antibiotic agent
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 |
|---|---|---|
| cardiopulmonary bypassRoutine use of cardiopulmonary bypass as needed during cardiac surgery | Procedure or surgery | – |
Primary outcome
Urinary NAG secretion
Time frame: 24 hours
Secretion pattern of NAG
1 secondary outcome
Development of AKI (acute kidney injury) according to AKIN criteria
Time frame: 72 hours
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 8 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Impairment, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 2 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: finished, as of the sponsor's last update on 8 Mar 2016. 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 Sweden. 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?
Urinary NAG secretion (time frame: 24 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 8 Mar 2016.