Acute Kidney Injury - Biomarkers in Major Abdominal Surgery
NCT ID: NCT04582747
Last Updated: 2020-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
500 participants
OBSERVATIONAL
2018-07-03
2020-03-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RDRI and NGAL in Acute Kidney Injury in Abdominal Surgery
NCT05929573
Assessment of Plasma and NGAL for the Early Prediction of Acute Kidney Injury After Cardiac Surgery in Adults Study
NCT02733328
Novel Biomarkers and Postoperative Kidney Injury in Radical Nephrectomy
NCT07088874
Study Evaluating Novel Biomarkers of AKI (Acute Kidney Injury) in Post-operative Patients
NCT02499185
To Examine Whether Urinary Partial Oxygen Pressure Measurements Are Indicative of the Postoperative Occurrence of Acute Kidney Injury (AKI) in Individuals Who Have Undergone Liver Transplantation
NCT06121167
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Surgery is a risk factor for acute kidney Injury (AKI). Surgery exposes patients to hypotension, sepsis, the infusion of blood products, ischaemia, oxidative stress and reperfusion injury.
Patients who develop AKI post operatively are susceptible to fluid overload, infections, and cardiac events. AKI confers an increased risk of chronic kidney disease and mortality. Studies assessing rates of AKI in general surgical patients place the frequency at 1-14%.
Established methods of assessing for AKI - products of nitrogen breakdown and urine output - have limitations. Serum creatinine and urea are affected by sex, nutritional status, blood in the gastrointestinal tract, and fluid resuscitation. Rises in serum creatinine become apparent once glomerular filtration has reduced by half. This potentially delays the use of reno-protective strategies.
Novel biomarkers have been investigated. These aim to verify the use of renal biomarkers as a method of identifying AKI more rapidly: It is hoped that reno-protective strategies could be adopted sooner.
Much work has concerned cardiac and transplant surgery. AKI rates have been quoted as high as 30% in this cohort. Results were initially encouraging for various biomarkers. One biomarker (Insulin like growth factor binding protein number 7 / Tissue inhibitor of metalloproteinases 2 - IGFBP-7/TIMP-2) has therefore been incorporated into Enhanced Recovery Programmes in such patients.
While research in cardiac and transplant surgery has been extensive, it has been limited with regards to abdominal surgery. Although rates of AKI are lower in this cohort, they still bear a significant burden of disease. At present, no biomarker has been found to be clinically useful in this setting.
Study Objectives
Primary
The validation of Urinary Biomarkers for use in the prediction of AKI in major abdominal surgery patients
Secondary
To assess the role different surgical sub-types and peri-operative factors have in causing AKI in Major Abdominal Surgery patients
Trial design
This is an observational study that will assess the use of Urinary biomarkers against conventional methods of assessing for AKI, the Kidney Disease, Improving Global Outcomes (KDIGO) criteria. The KDIGO criteria is based on increases in serum creatinine and reduction in urine output.
The biomarkers are:
IGFBP-7/TIMP-2 Neutrophil Gelatinase Associated Lipocalin (NGAL) Kidney Injury Molecule 1 (KIM-1) Dickkopf related protein 3 (DKK-3)
All patients undergoing major elective general surgery, and major abdominal gynaecological surgery will be included. All patients will have a urine sample taken 4 hours post operatively. This sample will be tested using the biomarkers. Written consent will be obtained from all participants.
The consent form has been designed with help of 10 surgical inpatients and 4 surgical nurses to ensure ease of understanding and a lack of medical jargon.
No changes are required to standard patient care. The urine sample obtained will be a catheter specimen.
Comparison of the novel biomarkers against conventional methods will be conducted using the KDIGO criteria. This entails regular urine output measurement, assessment of blood urea, electrolytes, and estimated glomerular filtration rate. Data regarding patient, operative and post-operative characteristics will be recorded on a purpose-built secure hospital intranet database.
Data Analysis
Performance of the biomarkers will be assessed using multiple logistic regression, and by conducting 'area under the receiver-operator curve (AUROC)' analysis. A risk prediction model will be created based on patient factors strongly associated with the primary endpoint. The performance of the risk prediction model will be assessed as a standalone test and in conjunction with the novel biomarker tests.
The sample size was calculated on the basis of previously published AUROC values for the test, the expected prevalence of AKI, and a desire for a 95% confidence interval around the calculated AUROC estimate for the study. This results in a target sample size of 471.
Hoped Aims of Research
The researchers hope that a novel test is found that can identify AKI sooner in an at-risk cohort of patients. If so, a further trial is intended: post-operative patients who are positive to the novel test will be randomised to a kidney protective 'bundle', and rates of AKI compared.
Ultimately, the intention is to greatly reduce a significant cause of post-operative morbidity, surgical complications, and mortality, through the judicious use of a non-invasive test.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Major abdominal Surgery patients
Major Abdominal Surgery Patients
Urinary Biomarkers (NGAL, DKK-3, IGFBP-7/TIMP-2, KIM-1)
Validation of Urinary biomarker tests for the rapid prediction of AKI.
No intervention is being proposed as part of the study. Concentrations of Urinary biomarkers will be obtained post operatively. These concentrations will be assessed to ascertain their predictive ability for the development of Acute Kidney Injury post-operatively.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Urinary Biomarkers (NGAL, DKK-3, IGFBP-7/TIMP-2, KIM-1)
Validation of Urinary biomarker tests for the rapid prediction of AKI.
No intervention is being proposed as part of the study. Concentrations of Urinary biomarkers will be obtained post operatively. These concentrations will be assessed to ascertain their predictive ability for the development of Acute Kidney Injury post-operatively.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Be able to provide informed consent
Exclusion Criteria
* Patients with pre-operative AKI
* Patients without baseline creatinine measurements
* Day case surgery
* Patients unable to consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Royal Surrey County Hospital NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AKI-BioMAS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.