A Study of changes in a kidney injury biomarker in patients undergoing heart surgery

A Descriptive Study of Serum Neutrophil Gelatinase-Associated Lipocalin in Patients Undergoing Cardiopulmonary Bypass

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000949987

Acronym

The NGAL study

Enrollment

Registered

2011-09-05

Start date

2011-10-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Injury to the kidney with loss of function is common after cardiac surgery especially in patients with previous kidney disease, old age, diabetes and the need for complex open heart surgery. The development of cardiac surgery associated acute kidney injury (CSA-AKI) is associated with increased length of ICU and hospital stay and increased risk of death. The development of the novel biomarker Neutrophil Gelatinase-Associated Lipocalin (NGAL) has proven to be an effective method for early detection of acute kidney injury (AKI). Early detection of AKI may facilitate early treatment, and may result in improved outcomes for patients with AKI. Standardisation of NGAL measurement has improved the reliability of serum NGAL as a marker of AKI. However the optimal timing for measurement of serum NGAL has yet to be fully elucidated, with different studies measuring NGAL at different time points. Accordingly we propose to study a group of 25 patients undergoing cardiopulmonary bypass, aiming to determine the optimal point or points at which to measure serum NGAL.

Interventions

Serum NGAL will be measured at baseline and then hourly following initiation of cardiopulmonary bypass for twelve hours, two hourly for six hours, and then at 24 and 48 hours post cardiopulmonary bypass.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Cardiac surgery patients in whom the use of cardiopulmonary bypass is planned and having one or more of the following risk factors for post operative kidney injury: *Age above 70 years *New York Heart Association class III/IV or impaired left ventricular function (left ventricular ejection fraction < 50%) *Valvular surgery or concomitant valvular and coronary artery bypass graft surgery *Redo cardiac surgery *Insulin dependent diabetes mellitus.

Exclusion criteria

*Age < 18 years *Pre-existing renal impairment (preoperative plasma creatinine concentration > 1.4mg/dL) *Preoperative insertion of an Intra Aortic Balloon Pump (IABP) *Emergency cardiac surgery *Planned off-pump cardiac surgery *Known blood borne infectious disease *Chronic inflammatory disease on immunosuppression *Chronic moderate to high dose corticosteroid therapy (>10mg/day prednisone or equivalent) *Enrolled in a conflicting research study

Outcome results