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

NCT04555382 | Unknown

• 1 other identifier: 2020-791
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

L-FABP, Acute Kidney Injury, diagnosis, biomarker

Outcome Measures

Primary Outcomes (1)

• the concentration of CAF, L-FABP and NGAL

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

  seven days after admission

Study Arms (2)

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

non-AKI group

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

Diagnostic Test: Blood and Urine

Interventions

Blood and Urine DIAGNOSTIC_TEST

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

AKI group; non-AKI group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The objects of study are the patients from the intensive care unit of the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022.

You may qualify if:

• the serum creatinine was increased above reference range at first when patients were included intensive care unit;
• renal dialysis and plasma exchange were never occured when patients were included in the study;
• patients who were included in the study stayed at two days in ICU.

You may not qualify if:

• patients who stayed in ICU for less than 24 hours;
• the serum creatinine was increased above reference range before ICU admission;
• kidney-related diseases were existed before ICU admission.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples were collected from the patients every twelve hours, and time was limited with a maximum of seven days for every patients. After centrifuging with 3000rpm for 5minutes, 1.5mL of supernate was taken into EP tube and stored in the refrigerator at -80℃

MeSH Terms

Conditions

Acute Kidney Injury; Disease

Interventions

Blood Specimen Collection; Urination

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Tao Zhihua

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Central Study Contacts

Sun Tao

CONTACT

15858168218; stzr@zju.edu.cn

Tao Zhihua

CONTACT

18258196858; zrtzh@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 18, 2020
• Study Start: August 15, 2020
• Primary Completion: February 15, 2022
• Study Completion: August 15, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)