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NAG-excretion During Cardiopulmonary Bypass

Effects of Cardiopulmonary Bypass on Urinary Secretion of NAG

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02410642
Acronym
CPBNAG
Enrollment
65
Registered
2015-04-07
Start date
2011-11-30
Completion date
2015-12-31
Last updated
2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

Keywords

cardiopulmonary bypass

Brief 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. 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.

Interventions

PROCEDUREcardiopulmonary bypass

Routine use of cardiopulmonary bypass as needed during cardiac surgery

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Expected cardiopulmonary bypass time exceeding 60 minutes * Elective surgery

Exclusion criteria

* End-stage kidney disease with dialysis * Ongoing treatment with nephrotoxic antibiotic agent

Design outcomes

Primary

MeasureTime frameDescription
Urinary NAG secretion24 hoursSecretion pattern of NAG

Secondary

MeasureTime frameDescription
Development of AKI (acute kidney injury) according to AKIN criteria72 hoursDevelopment of AKI (acute kidney injury) according to AKIN criteria

Other

MeasureTime frameDescription
Perioperative factors influencing NAG-secretion24 hoursMultivariate analysis of factors that might influence NAG-excretion

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026