Acute Kidney InjuryNCT05691621
Galectin-3 in Septic and Non-septic Acute Kidney Injury
An observational study of Acute Kidney Injury and Sepsis, run by Fengyun Wang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Sepsis
- What is being tested?
- Standard Reagents, Whole Blood
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Aug 2023
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Critically ill patients with sepsis or AKI, or non-sepsis and non-AKI patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Critical Care Department, First People's Hospital of Foshan
Foshan
Fengyun Wang, Doctor, 08618162429717, dr-w@qq.com
Xinhua Qiang, Master, dr-w@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury, Sepsis
- Being tested
- Standard Reagents, Whole Blood
- Medical subject headings
- Acute Kidney Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Reagents, Whole BloodDrug
Also called Urine samples within 24 hours after ICU admission
All patients receive standard treatment, only their blood and urine samples are needed
| Study group | Role | What they receive |
|---|---|---|
| septic AKI: S-AKI | Septic patients with AKI Receives: Drug: Standard Reagents, Whole Blood | |
| non-septic AKI: non-S AKI | Non-septic critically ill patients with AKI. Receives: Drug: Standard Reagents, Whole Blood | |
| non-AKI Non-AKI | Critically ill patients without sepsis and AKI. Receives: Drug: Standard Reagents, Whole Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of Gal3
The levels of Gal3 in septic AKI, non-septic AKI, and non-AKI patients in the ICU
Measured: 2023-01~2023-08
Secondary outcomes (8)
Mortality
mortality at 28 days after ICU admission
Measured: 2023-01~2023-08
Length of stay in the ICU
The days of patients in the ICU
Measured: 2023-01~2023-08
Renal replacement therapy incidence
The incidence of RRT during the trial
Measured: 2023-01~2023-08
Cardiovascular events incidence
The incidence of cardiovascular events during the trial
Measured: 2023-01~2023-08
IL-6
Interleukin-6
Measured: 2023-01~2023-08
HMGB1
High mobility group box 1
Measured: 2023-01~2023-08
NGAL
Neutrophil gelatinase-associated lipid carrier protein
Measured: 2023-01~2023-08
TIMP-2
Tissue inhibitor of metalloproteinase 2
Measured: 2023-01~2023-08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Fengyun Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan University
- Responsible party
- Sponsor-investigator, Fengyun Wang, First People's Hospital of Foshan
- Investigators
- Fengyun Wang, Doctor, Principal investigator, First People's Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691621
- Sponsor's protocol ID
- FirstPeopleFoshan
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Galectin-3 in Septic and Non-septic Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05691621
- Acronym / sponsor ID
- FirstPeopleFoshan
- Conditions
- Acute Kidney Injury, Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fengyun WangUniversity, hospital or other
- Collaborators
- Wuhan University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| septic AKI: S-AKI | – | Drug: Standard Reagents, Whole BloodSeptic patients with AKI |
| non-septic AKI: non-S AKI | – | Drug: Standard Reagents, Whole BloodNon-septic critically ill patients with AKI. |
| non-AKI Non-AKI | – | Drug: Standard Reagents, Whole BloodCritically ill patients without sepsis and AKI. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with sepsis or AKI, or non-sepsis and non-AKI patients.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Reagents, Whole BloodAlso: Urine samples within 24 hours after ICU admissionAll patients receive standard treatment, only their blood and urine samples are needed | Drug | non-AKI Non-AKI, non-septic AKI: non-S AKI, septic AKI: S-AKI |
Primary outcome
The levels of Gal3
Time frame: 2023-01~2023-08
The levels of Gal3 in septic AKI, non-septic AKI, and non-AKI patients in the ICU
8 secondary outcomes
Mortality
Time frame: 2023-01~2023-08
Length of stay in the ICU
Time frame: 2023-01~2023-08
Renal replacement therapy incidence
Time frame: 2023-01~2023-08
Cardiovascular events incidence
Time frame: 2023-01~2023-08
IL-6
Time frame: 2023-01~2023-08
HMGB1
Time frame: 2023-01~2023-08
NGAL
Time frame: 2023-01~2023-08
TIMP-2
Time frame: 2023-01~2023-08
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengyun Wang, Doctor principal investigator
First People's Hospital of Foshan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Sepsis, run by Fengyun Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengyun Wang, Doctor (18162429717, dr-w@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The levels of Gal3 (time frame: 2023-01~2023-08). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.