NAG-excretion During Cardiopulmonary Bypass

NCT ID: NCT02410642

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Renal Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

cardiopulmonary bypass

Routine use of cardiopulmonary bypass as needed during cardiac surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lukas Lannemyr

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of thoracic anesthesia, Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

SahlgrenskaUHThoraxLL2

Identifier Type: -

Identifier Source: org_study_id