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

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ClinicalTrials.gov Identifier: NCT02733328
Recruitment Status : Recruiting
First Posted : April 11, 2016
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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 Type : Observational
Estimated Enrollment : 156 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 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733328


Contacts
Contact: Lorraine Jacques 01902 695064 lorraine.jacques@nhs.net

Locations
United Kingdom
The Royal Wolverhampton NHS Trust Recruiting
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Contact: R Gama       rousseau.gama@nhs.net   
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust
Investigators
Principal Investigator: Rousseau Gama The Royal Wolverhampton NHS Trust

Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02733328     History of Changes
Other Study ID Numbers: 2015LAB80
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Royal Wolverhampton Hospitals NHS Trust:
Cardio-pulmonary bypass (CPB)
renal replacement therapy (RRT)
enzyme-linked immunosorbent assay (ELISA)

Additional relevant MeSH terms:
Wounds and Injuries
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Acute Kidney Injury
Urologic Diseases
Renal Insufficiency