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Completed

NCT Number: NCT02410642

NAG-excretion During Cardiopulmonary Bypass

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of thoracic anesthesia, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiopulmonary bypass

Procedure

Routine use of cardiopulmonary bypass as needed during cardiac surgery

Primary outcomes

  1. Urinary NAG secretion

    Time frame: 24 hours

    Secretion pattern of NAG

Secondary outcomes

  1. Development of AKI (acute kidney injury) according to AKIN criteria

    Time frame: 72 hours

    Development of AKI (acute kidney injury) according to AKIN criteria

Other outcomes

  1. Perioperative factors influencing NAG-secretion

    Time frame: 24 hours

    Multivariate analysis of factors that might influence NAG-excretion

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

Effects of Cardiopulmonary Bypass on Urinary Secretion of NAG

Acronym: CPBNAG

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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