Skip to main content
OpenTrials
Completed

NCT Number: NCT02733328

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPB Surgery

Procedure

Primary outcomes

  1. 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").

    Time frame: 24 months

Secondary outcomes

  1. Total stay in Intensive Treatment Unit (ITU) / High-Dependency Unit (HDU)

    Time frame: 24 months

  2. Total length of hospital stay

    Time frame: 24 months

  3. Mortality

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: NGAL

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Apr 11, 2016
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.