Acute Kidney Injury - Biomarkers in Major Abdominal Surgery
AKI-BioMAS
Urinary Biomarkers for the Prediction of Acute Kidney Injury Following Major Abdominal Surgery
1 other identifier
observational
500
1 country
1
Brief Summary
To validate Urinary Biomarkers for the prediction of AKI in major abdominal surgery patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2018
CompletedFirst Submitted
Initial submission to the registry
September 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
October 12, 2020
CompletedOctober 12, 2020
October 1, 2020
1.7 years
September 18, 2019
October 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The diagnostic performance (expressed as the 'Area under the receiver-operator curve') of Urinary Biomarkers for the rapid prediction of Acute Kidney Injury in Major Abdominal Surgery patients.
Conventional renal function measurement - assessing blood creatinine - often does not identify Acute Kidney Injury until 48 hours has passed from the time of insult. It is hypothesised that the studied urinary biomarkers may be able to identify patients who develop AKI 4 hours post-operatively.
The study aims to assess the diagnostic performance of the biomarkers to predict the development of AKI within 3 days of the surgical procedure. Renal function will be assessed daily within this time frame.
Study Arms (1)
Major abdominal Surgery patients
Major Abdominal Surgery Patients
Interventions
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
All patients undergoing major elective general surgery, and major abdominal gynaecological surgery will be included
You may qualify if:
- Patients aged over 18 undergoing major Hepatobiliary, Oesophagogastric, Colorectal or abdominal Gynaecological Surgery at the Royal Surrey County Hospital. Patients undergoing Liver Transplant Surgery at King's College Hospital
- Be able to provide informed consent
You may not qualify if:
- Patients requiring renal replacement therapy prior to the study
- Patients with pre-operative AKI
- Patients without baseline creatinine measurements
- Day case surgery
- Patients unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Biospecimen
Urine samples from post-operative abdominal surgery patients
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2019
First Posted
October 12, 2020
Study Start
July 3, 2018
Primary Completion
March 3, 2020
Study Completion
March 3, 2020
Last Updated
October 12, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share
Participants are anonymised in the study. Demographic and clinical data will be provided as part of the study write up