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

Completed

• Conditions: Chronic Kidney Disease (CKD); End Stage Renal Disease (ESRD); Neutrophil Gelatinase-associated Lipocalin (NGAL); Urine Creatinine (UCr); Acute Kidney Injury (AKI); Estimated Glomerular Filtration Rate (eGFR); Serum Creatinine (SCr); Urine Albumin (UAlb)
• Interventions: Procedure: CPB Surgery

• Registration Number: NCT02733328
• Lead Sponsor: The Royal Wolverhampton Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-11
• Study Start: 2016-05
• Primary Completion: 2018-11-17
• Study Completion: 2020-09-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

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.

Exclusion Criteria

• Patients already on renal replacement therapy (RRT)
• Post-renal transplant patients
• Emergency surgery
• Patients <18 yrs of age
• Pregnancy
• Patients already involved with other on-going clinical studies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-AKI Patients	CPB Surgery	Patients without AKI
AKI Patients	CPB Surgery	Patients with AKI

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

The Royal Wolverhampton NHS Trust; 🇬🇧 Wolverhampton, West Midlands, United Kingdom