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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691621
• Other study ID #: FirstPeopleFoshan
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis
• Wounds and Injuries

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