Galectin-3 in Septic and Non-septic Acute Kidney Injury

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
A Prospective Observational Study of Galectin-3 in Septic and Non-septic Acute Kidney Injury

Conditions
-----------------
Sepsis, Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: Standard Reagents, Whole Blood


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| septic AKI: S-AKI<br>Septic patients with AKI | Drug: Standard Reagents, Whole Blood<br>* All patients receive standard treatment, only their blood and urine samples are needed<br>* Other names: Urine samples within 24 hours after ICU admission;|
| non-septic AKI: non-S AKI<br>Non-septic critically ill patients with AKI. | Drug: Standard Reagents, Whole Blood<br>* All patients receive standard treatment, only their blood and urine samples are needed<br>* Other names: Urine samples within 24 hours after ICU admission;|
| non-AKI Non-AKI<br>Critically ill patients without sepsis and AKI. | Drug: Standard Reagents, Whole Blood<br>* All patients receive standard treatment, only their blood and urine samples are needed<br>* Other names: Urine samples within 24 hours after ICU admission;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | mortality at 28 days after ICU admission | 2023-01 2023-08 | 
| Length of stay in the ICU | The days of patients in the ICU | 2023-01 2023-08 | 
| Renal replacement therapy incidence | The incidence of RRT during the trial | 2023-01 2023-08 | 
| Cardiovascular events incidence | The incidence of cardiovascular events during the trial | 2023-01 2023-08 | 
| IL-6 | Interleukin-6 | 2023-01 2023-08 | 
| HMGB1 | High mobility group box 1 | 2023-01 2023-08 | 
| NGAL | Neutrophil gelatinase-associated lipid carrier protein | 2023-01 2023-08 | 
| TIMP-2 | Tissue inhibitor of metalloproteinase 2 | 2023-01 2023-08 |