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

Recruiting

• Conditions: Sepsis; Acute Kidney Injury
• Interventions: Drug: Standard Reagents, Whole Blood

• Registration Number: NCT05691621
• Lead Sponsor: Fengyun Wang

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.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-19
• Last Update Submitted: 2023-01-19
• Study First Posted: 2023-01-20
• Last Update Posted: 2023-01-20
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
septic AKI: S-AKI	Standard Reagents, Whole Blood	Septic patients with AKI
non-septic AKI: non-S AKI	Standard Reagents, Whole Blood	Non-septic critically ill patients with AKI.
non-AKI Non-AKI	Standard Reagents, Whole Blood	Critically ill patients without sepsis and AKI.

Primary Outcome Measures

Name	Time	Method
The levels of Gal3	2023-01~2023-08	The levels of Gal3 in septic AKI, non-septic AKI, and non-AKI patients in the ICU

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Critical Care Department, First People's Hospital of Foshan; 🇨🇳 Foshan, China