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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 405

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
      • The Royal Wolverhampton NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

156 (54 AKI;102 non-AKI) patients undergoing CPB surgery, including those with CKD and multiple co-morbidities

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AKI Patients; Patients with AKI	Procedure: CPB Surgery
Non-AKI Patients; Patients without AKI	Procedure: CPB Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: The Royal Wolverhampton Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): September 7, 2020
• Study Completion (ACTUAL): September 7, 2020

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (ESTIMATE): April 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cardio-pulmonary bypass (CPB); renal replacement therapy (RRT); enzyme-linked immunosorbent assay (ELISA)
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Wounds and Injuries; Kidney Failure, Chronic; Acute Kidney Injury
• Other Study ID Numbers: 2015LAB80

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO