NCT05691621

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 8, 2023

Last Update Submit

January 19, 2023

Conditions

Acute Kidney InjurySepsis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Mortality

    2023-01~2023-08

  • Length of stay in the ICU

    2023-01~2023-08

  • Renal replacement therapy incidence

    2023-01~2023-08

  • Cardiovascular events incidence

    2023-01~2023-08

  • IL-6

    2023-01~2023-08

  • +3 more secondary outcomes

Study Arms (3)

septic AKI: S-AKI

Septic patients with AKI

Drug: Standard Reagents, Whole Blood

non-septic AKI: non-S AKI

Non-septic critically ill patients with AKI.

Drug: Standard Reagents, Whole Blood

non-AKI Non-AKI

Critically ill patients without sepsis and AKI.

Drug: Standard Reagents, Whole Blood

Interventions

Standard Reagents, Whole BloodDRUG

All patients receive standard treatment, only their blood and urine samples are needed

Also known as: Urine samples within 24 hours after ICU admission
non-AKI Non-AKInon-septic AKI: non-S AKIseptic AKI: S-AKI

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. 18 years old or more.
  • \. The patient himself or his agent is able to provide informed consent and provide adequate information for the endpoint assessment.
  • \. 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.

You may not qualify if:

  • \. Age less 18 years old.
  • \. 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.
  • \. Patients with an expected survival time of less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Critical Care Department, First People's Hospital of Foshan

Foshan, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood or urine samples within 24 hours after ICU admission.

MeSH Terms

Conditions

Acute Kidney InjurySepsis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fengyun Wang, Doctor

    First People's Hospital of Foshan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengyun Wang, Doctor

CONTACT

18162429717dr-w@qq.com

Xinhua Qian, Master

CONTACT

075781263631474352852@qq.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
28 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 20, 2023

Study Start

January 1, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)