NCT05450523|Completed
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Sponsor study identifier
observational
220
1 country
1
Study Start
December 28, 2021
Actual (reported)Primary Completion
September 7, 2022
Actual (reported)Study Completion
September 7, 2022
Actual (reported)According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 7, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 28, 2021
Actual (reported)June 27, 2022
Actual (reported)July 8, 2022
Actual (reported)September 7, 2022
Actual (reported)September 7, 2022
Actual (reported)Assessment reagent test results and clinical reference standard statistics
The peritoneal dialysis effluent collected from the subjects was tested blindly with the assessment reagents, and the test results were compared with the clinical reference standards. By evaluating the clinical sensitivity and specificity of the assessment reagents, the feasibility of clinical application of the assessment reagents was evaluated.
8 months
Statistical analysis of non-professional self-testing test
There is no need to train non-professionals. After reading the instructions and labels, non-professionals can evaluate their ability to understand key information such as instructions and packaging labels through questionnaires; Research, comparison of test results of different forms of reagents, and comparison with professional test results to evaluate their operational capabilities.
8 months
Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis.
The first affiliated hosital of Nangchang university
Nanchang, Jiangxi, China
Qinkai Chen, Chief physician
The first affiliated hosital of Nangchang university
220 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2022
First Posted
July 8, 2022
Study Start
December 28, 2021
Actual (reported)Improved Diagnosis of Peritoneal Dialysis Peritonitis by Calorimetry
Contact the study team to confirm eligibility.
Primary Completion
September 7, 2022
Actual (reported)Study Completion
September 7, 2022
Actual (reported)Last Updated
March 21, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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