Assessment of Plasma and NGAL for the Early Prediction of Acute Kidney Injury After Cardiac Surgery in Adults Study

Sponsor

The Royal Wolverhampton Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02733328

Collaborator

(none)

405

Enrollment

Location

52.2

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to recruit 156 (54 Acute Kidney Injury (AKI);102 non-AKI) patients undergoing Cardio pulmonary bypass (CPB) surgery, including those with Chronic Kidney Disease (CKD) and multiple co-morbidities. Urine and blood samples collected pre-operatively and then 0, 3, 6 and 18 hours post-CPB will be stored at -80oC until batch analysed for NGAL using the Abbott and BioPorto assays. AKI - defined as a ≥50% rise in serum creatinine (SCr) over baseline, or the requirement for renal replacement therapy (RRT). SCr will be measured pre-operatively (baseline), then 12 hourly for the first 48 hrs post-CPB and thereafter 24 hourly for 5 days. Clinical data collected will include patient demographics, co-morbidities, drug history, pre-operative renal function, surgery details (type, length, CPB time etc.), length of Intensive treatment unit and hospital stay and post-operative complications. Data will then be analysed comparing the two NGAL tests to find out which is superior, whether it is better to use blood or urine and to define optimal NGAL cut-offs and sample timing for predicting AKI. Both the Abbott and BioPorto assays will subject to a laboratory method evaluation prior to the analysis of any patient specimens in order to verify that their performance is acceptable and meets the manufacturer's claims. This will involve measuring the standard parameters used to assess laboratory assay performance e.g. imprecision (reproducibility), linearity, recovery and method comparison etc.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury (AKI) Chronic Kidney Disease (CKD) End Stage Renal Disease (ESRD) Estimated Glomerular Filtration Rate (eGFR) Neutrophil Gelatinase-associated Lipocalin (NGAL) Serum Creatinine (SCr) Urine Creatinine (UCr) Urine Albumin (UAlb)	Procedure: CPB Surgery

Study Design

Study Type:

Observational

Actual Enrollment :

405 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Assessment of Plasma and NGAL for the Early Prediction of Acute Kidney Injury

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Sep 7, 2020

Actual Study Completion Date :

Sep 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
AKI Patients Patients with AKI	Procedure: CPB Surgery
Non-AKI Patients Patients without AKI	Procedure: CPB Surgery

Arm

Intervention/Treatment

AKI Patients

Patients with AKI

Procedure: CPB Surgery

Non-AKI Patients

Patients without AKI

Procedure: CPB Surgery

Outcome Measures

Primary Outcome Measures

Acute Kidney Injury (AKI) or requirement for RRT with 7 days of surgery. AKI is defined as a ≥50% rise in serum creatinine over baseline pre-operative levels (RIFLE stage "R"). [24 months]

Secondary Outcome Measures

Total stay in Intensive Treatment Unit (ITU) / High-Dependency Unit (HDU) [24 months]
Total length of hospital stay [24 months]
Mortality [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients undergoing cardiac surgery,
Including patients with both normal renal function (eGFR >60 mL/min) and pre-operative CKD (eGFR < 60 mL/min),
Include patients with other existing co-morbidity (e.g. diabetes, vascular disease, hypothyroidism) plus those with risk factors of AKI e.g. nephrotoxic drugs.