NAG-excretion During Cardiopulmonary Bypass

Renal Impairment Clinical Trial

— CPBNAG  

Official title:

Effects of Cardiopulmonary Bypass on Urinary Secretion of NAG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410642
• Other study ID #: SahlgrenskaUHThoraxLL2
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: March 7, 2016
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical 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. We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary bypass, and explore possible associated variables.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Procedure:
• cardiopulmonary bypass
Routine use of cardiopulmonary bypass as needed during cardiac surgery

Locations

Country	Name	City	State
Sweden	Department of thoracic anesthesia, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perioperative factors influencing NAG-secretion	Multivariate analysis of factors that might influence NAG-excretion	24 hours	No
Primary	Urinary NAG secretion	Secretion pattern of NAG	24 hours	No
Secondary	Development of AKI (acute kidney injury) according to AKIN criteria	Development of AKI (acute kidney injury) according to AKIN criteria	72 hours	No