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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05691621
Other study ID # FirstPeopleFoshan
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date August 31, 2023

Study information

Verified date January 2023
Source First People's Hospital of Foshan
Contact Fengyun Wang, Doctor
Phone 18162429717
Email dr-w@qq.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Acute kidney injury (AKI) is a common critical condition with high morbidity and mortality. The level of circulating Galectin-3 (Gal3) largely depends on renal function, so it is elevated in patients with AKI or CKD; elevated Gal3 also aggravates the progression of CKD after the onset of AKI. The proinflammatory and profibrotic properties of Gal3 may render it to be one of the key molecules mediating AKI, CKD, and cardiorenal syndrome. In this prospective observational study, the investigators will explore the differences of Gal3 levels among septic AKI, non-septic AKI, and non-AKI patients and its correlation with prognosis, inflammation, and disease severity in the ICU.


Description:

Acute kidney injury (AKI) is a common critical condition with high morbidity and mortality. Not only can AKI cause death in the acute phase, but also can it be associated with the development of chronic kidney disease (CKD) or the progression of CKD. Galectins are members of a lectin family widely expressed in vertebrates, among which galectin-3 (Gal3) is the most studied one. The level of circulating Gal3 largely depends on renal function, so it is elevated in patients with AKI or CKD; elevated Gal3 also aggravates the progression of CKD after the onset of AKI. The proinflammatory and profibrotic properties of Gal3 may render it to be one of the key molecules mediating AKI, CKD, and cardiorenal syndrome. However, the mechanisms of AKI differ from different etiologies, and the process and extent of levels of Gal3 may be also different, so its predictive value in prognosis may vary in different types of AKI. In critically ill patients, AKI is a common complication of sepsis, and sepsis is the most common trigger of AKI. In this prospective observational study, the investigators will explore the differences of Gal3 levels among septic AKI, non-septic AKI, and non-AKI patients and its correlation with prognosis, inflammation, and disease severity in the ICU.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - 1. 18 years old or more. - 2. The patient himself or his agent is able to provide informed consent and provide adequate information for the endpoint assessment. - 3. Renal function was stable before this onset, and there was no evidence of plasma creatinine rising by 0.3 mg/dL within 3 months of study entry and not receiving RRT. Exclusion Criteria: - 1. Age less 18 years old. - 2. There were previous acute kidney injury, kidney transplantation, chronic kidney disease, or with a glomerular filtration rate of less than 30 mL/min, or hepatorenal syndrome, or pregnancy. - 3. Patients with an expected survival time of less than 6 months.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Standard Reagents, Whole Blood
All patients receive standard treatment, only their blood and urine samples are needed

Locations

Country Name City State
China Critical Care Department, First People's Hospital of Foshan Foshan

Sponsors (2)

Lead Sponsor Collaborator
Fengyun Wang Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The levels of Gal3 The levels of Gal3 in septic AKI, non-septic AKI, and non-AKI patients in the ICU 2023-01~2023-08
Secondary Mortality mortality at 28 days after ICU admission 2023-01~2023-08
Secondary Length of stay in the ICU The days of patients in the ICU 2023-01~2023-08
Secondary Renal replacement therapy incidence The incidence of RRT during the trial 2023-01~2023-08
Secondary Cardiovascular events incidence The incidence of cardiovascular events during the trial 2023-01~2023-08
Secondary IL-6 Interleukin-6 2023-01~2023-08
Secondary HMGB1 High mobility group box 1 2023-01~2023-08
Secondary NGAL Neutrophil gelatinase-associated lipid carrier protein 2023-01~2023-08
Secondary TIMP-2 Tissue inhibitor of metalloproteinase 2 2023-01~2023-08
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