Combining CAF, L-FABP and NGAL as a Potentially Diagnostic Model for Acute Kidney Injury.

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04555382
Collaborator
(none)
100
1
24
4.2

Study Details

Study Description

Brief Summary

Acute kidney injury was a common clinical complication, and many diseases were associated with a high risk of occurrence of AKI. We explored the clinical utility of serum CAF, L-FABP and NGAL by constructing a diagnostic model for identification of ICU patients at risk for AKI and distinguish different etiologies of AKI.

This observational cohort study included one hundred patients who had been in ICU from the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. Blood and urine samples were collected every 12 hours until 7 days. The time of staying with ICU less than 2 days were removed. CAF, L-FABP and NGAL was measured based on the platform of Chemiluminescent Immunoassay, and assessed the diagnostic value of the occurrence of AKI. By constructing an effective diagnostic model to provide effective clinical decision-marking for early intervention.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood and Urine

Detailed Description

The observational cohort study included one hundred patients who were from the intensive care unit of the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines as renal function was suddenly decreased within 48 hours and serum creatinine increased at least 0.3mg/dL, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours. The staging criteria of AKI as follows: stage I means serum creatinine higher than baseline between 1.5times and 1.9 times, or serum creatinine increased at least 26.5μmol/L, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours; stage II means serum creatinine higher than baseline between 2.0 times and 2.9 times, or urine volume less than 0.5mL/Kg per hour for 12hours; stage III means serum creatinine higher than baseline 3.0 times, or serum creatinine higher than baseline 353.6μmol/L, or started renal replacement therapy. Patients who stayed in the ICU for less than 24 hours and whose serum creatinine had increased above normal reference range on the first day of ICU were excluded.

Collecting the blood and urine samples of the patients regularly every twelve hours, centrifuging samples in 3000rpm for 5 minutes, freezing at -80℃, all patients' clinical information should be recorded by name, age ,sex, BMI index, hypertension, diabetes, cardiac disease, and so on. All patients have written informed contents and this study was approved by the Second Affiliated Hospital of Zhejiang University School of Medicine.NGAL, CAF and L-FABP was measured by chemiluminescent immunoassay with Robust i1000.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Association Between CAF, L-FABP and NGAL and the Occurence of Acute Kidney Injury : a Potential Diagnostic Model of Three Biomarkers.
Actual Study Start Date :
Aug 15, 2020
Anticipated Primary Completion Date :
Feb 15, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
AKI group

this group are included patients who have not occured acute kidney injury at first, however acute kidney injury are occured soon afterwards during the observation period.

Diagnostic Test: Blood and Urine
Blood and urine samples are collected every twelve hours when the patients are included in the study during observation period.

non-AKI group

this group are included patients who have not occured acute kidney injury during the observation period.

Diagnostic Test: Blood and Urine
Blood and urine samples are collected every twelve hours when the patients are included in the study during observation period.

Outcome Measures

Primary Outcome Measures

  1. the concentration of CAF, L-FABP and NGAL [seven days after admission]

    the concentration of CAF, L-FABP and NGAL of blood and urine samples of every patients are measured by Chemiluminescent Immunoassay

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. the serum creatinine was increased above reference range at first when patients were included intensive care unit;

  2. renal dialysis and plasma exchange were never occured when patients were included in the study;

  3. patients who were included in the study stayed at two days in ICU.

Exclusion Criteria:
  1. patients who stayed in ICU for less than 24 hours;

  2. the serum creatinine was increased above reference range before ICU admission;

  3. kidney-related diseases were existed before ICU admission.

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Tao Zhihua, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04555382
Other Study ID Numbers:
  • 2020-791
First Posted:
Sep 18, 2020
Last Update Posted:
Oct 8, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2020