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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Acute Kidney Injury
• Intervention / Treatment: Drug: Standard Reagents, Whole Blood

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Fengyun Wang, Doctor; Phone Number: 18162429717; Email: dr-w@qq.com
• Study Contact Backup: Name: Xinhua Qian, Master; Phone Number: 075781263631; Email: 474352852@qq.com

Study Locations

• China
  • Foshan, China
    • Recruiting
    • Critical Care Department, First People's Hospital of Foshan
    • Contact: Fengyun Wang, Doctor; Phone Number: 08618162429717; Email: dr-w@qq.com
    • Contact: Xinhua Qiang, Master; Email: dr-w@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients with sepsis or AKI, or non-sepsis and non-AKI patients.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: Fengyun Wang
• Collaborators: Wuhan University
• Investigators: Principal Investigator: Fengyun Wang, Doctor, First People's Hospital of Foshan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: FirstPeopleFoshan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No