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

NCT ID: NCT02733328

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 405 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-09-07

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.

Conditions

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)

Study Design

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

Study Groups

AKI Patients

Patients with AKI

CPB Surgery

Intervention Type: PROCEDURE

Non-AKI Patients

Patients without AKI

CPB Surgery

Intervention Type: PROCEDURE

Interventions

CPB Surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

Sponsors

The Royal Wolverhampton Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rousseau Gama

Role: PRINCIPAL_INVESTIGATOR

The Royal Wolverhampton NHS Trust

Locations

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, United Kingdom

Countries

United Kingdom

Other Identifiers

2015LAB80

Identifier Type: -

Identifier Source: org_study_id