Acute Kidney InjuryNCT06197828
Novel Biomarkers for Early Renal Injury in Children With Sepsis
An observational study of Acute Kidney Injury and Sepsis, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Toxicosis often leads to multiple organ failure (MODS), with the kidney being the primary target organ due to its sensitivity to infection and ischemia. The kidney's vulnerability makes it a potential early indicator of organ failure, implying that further organ failure may occur later, thereby increasing the risk of… Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Acute Kidney Injury, Sepsis, Gout Flare
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Dec 2024
- 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 1 year to 16 years
- All sexes
- Child
Study population: Between the period of May 2021 to December 2024, the study focused on patients who were admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days. Specifically, patients with a diagnosis of sepsis were selected based on the internationally recognized 2005 standard for childhood sepsis, the 2012 Surviving Sepsis Campaign guidelines for pediatric sepsis, and the 2015 expert consensus on sepsis criteria for Chinese children with septic shock. The age range of the patients included in the study spanned from 1 month to 16 years old
Who may be able to join
- From May 2021 to December 2024, the study focused on patients admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days. Specifically, patients with severe infection and those who underwent pediatric neurosurgery were diagnosed with sepsis according to the international standard for childhood sepsis established in 2005, the 2012 Surviving Sepsis Campaign guidelines for pediatric sepsis, and the 2015 expert consensus on sepsis criteria for Chinese children with septic shock. The age range of the patients included in the study spanned from 1 month to 16 years old.
Who cannot join
- Children who enter PICU 24 hours and die or exit PICU within 24 hours; Genetic metabolic diseases; Congenital immune deficiency; Can't sign an informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200082
About this study
Official title: Development and Application of Novel Biomarkers and Clinical Indicators for Early Renal Injury in Children With Sepsis
Toxicosis often leads to multiple organ failure (MODS), with the kidney being the primary target organ due to its sensitivity to infection and ischemia. The kidney's vulnerability makes it a potential early indicator of organ failure, implying that further organ failure may occur later, thereby increasing the risk of patient mortality. Several studies conducted on sepsis patients in the Pediatric Intensive Care Unit (PICU) have revealed that 40.32% of sepsis patients experienced complications with acute kidney injury (AKI), and the case fatality rate could rise to 70% once AKI occurred. The Kidney Disease Improving Global Outcomes (KDIGO) scale is commonly used as a diagnostic criterion for AKI. However, the kidney's robust reserve function poses a challenge for early identification, diagnosis, and intervention of AKI since significant increases in creatinine levels and a sharp decrease in urine volume already indicate severe kidney damage. This situation calls for the development of alternative methods.
In our previous study, we discovered a strong correlation between urinary oxygen partial pressure and renal organ function impairment in children with sepsis. Building upon traditional biochemical indicators such as blood lactic acid levels, we will incorporate non-invasive tests like urine partial pressure of oxygen, renal ultrasound, and cardiac ultrasound, as well as novel markers like KIM-1, to establish a model for early recognition and assessment of kidney damage in children with sepsis. By utilizing commonly used biomarkers and the precise effects of urinary oxygen partial pressure, we aim to improve early identification and accurate intervention evaluation for pediatric sepsis kidney injury. This research will provide a crucial foundation for the development of early warning systems, diagnostic guidelines, and treatment protocols for pediatric sepsis kidney injury.
- Conditions
- Acute Kidney Injury, Sepsis, Gout Flare
- Being tested
- This study is an observational studie which have no intervention
- Keywords
- pediatric, kidney injury, sepsis, gut microbiota, blood metabolome
- 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.
This study is an observational studie which have no interventionOther
This study is an observational studie which have no intervention
| Study group | Role | What they receive |
|---|---|---|
| Sepsis-associated acute kidney injury | Between May 2021 and December 2024, patients admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days were included in the study. Specifically, patients diagnosed with sepsis were selected based on the 2005 international standard for childhood sepsis, the 2012 Surviving Sepsis Campaign guidelines for pediatric sepsis, and the 2015 expert consensus on sepsis criteria for Chinese children with septic shock. The age range of the patients included in the study varied from 1 month to 16 years old. Receives: Other: This study is an observational studie which have no intervention | |
| Patients without sepsis In ICU | patients admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days and those without sepsis were included in the study. Receives: Other: This study is an observational studie which have no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota
Alterations and specific biomarkers of the intestinal microbiota in patients with sepsis complicated by acute kidney injury
Measured: the first three day after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 May 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (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.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaya Xu, M.S., Study director, Shanghai Jiaotong University School of Medicine Xinhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197828
- Sponsor's protocol ID
- XH-23-003
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of Novel Biomarkers and Clinical Indicators for Early Renal Injury in Children With Sepsis
- ClinicalTrials.gov ID
- NCT06197828
- Acronym / sponsor ID
- XH-23-003
- Conditions
- Acute Kidney Injury, Sepsis, Gout Flare
- Keywords
- pediatric, kidney injury, sepsis, gut microbiota, blood metabolome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Jan 2024 (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.
Toxicosis often leads to multiple organ failure (MODS), with the kidney being the primary target organ due to its sensitivity to infection and ischemia. The kidney's vulnerability makes it a potential early indicator of organ failure, implying that further organ failure may occur later, thereby increasing the risk of patient mortality. Several studies conducted on sepsis patients in the Pediatric Intensive Care Unit (PICU) have revealed that 40.32% of sepsis patients experienced complications with acute kidney injury (AKI), and the case fatality rate could rise to 70% once AKI occurred. The Kidney Disease Improving Global Outcomes (KDIGO) scale is commonly used as a diagnostic criterion for AKI. However, the kidney's robust reserve function poses a challenge for early identification, diagnosis, and intervention of AKI since significant increases in creatinine levels and a sharp decrease in urine volume already indicate severe kidney damage. This situation calls for the development of alternative methods.
In our previous study, we discovered a strong correlation between urinary oxygen partial pressure and renal organ function impairment in children with sepsis. Building upon traditional biochemical indicators such as blood lactic acid levels, we will incorporate non-invasive tests like urine partial pressure of oxygen, renal ultrasound, and cardiac ultrasound, as well as novel markers like KIM-1, to establish a model for early recognition and assessment of kidney damage in children with sepsis. By utilizing commonly used biomarkers and the precise effects of urinary oxygen partial pressure, we aim to improve early identification and accurate intervention evaluation for pediatric sepsis kidney injury. This research will provide a crucial foundation for the development of early warning systems, diagnostic guidelines, and treatment protocols for pediatric sepsis kidney injury.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis-associated acute kidney injury | – | Other: This study is an observational studie which have no interventionBetween May 2021 and December 2024, patients admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days were included in the study. Specifically, patients diagnosed with sepsis were selected based on the 2005 international standard for childhood sepsis, the 2012 Surviving Sepsis Campaign guidelines for pediatric sepsis, and the 2015 expert consensus on sepsis criteria for Chinese children with septic shock. The age range of the patients included in the study varied from 1 month to 16 years old. |
| Patients without sepsis In ICU | – | Other: This study is an observational studie which have no interventionpatients admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days and those without sepsis were included in the study. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Between the period of May 2021 to December 2024, the study focused on patients who were admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days. Specifically, patients with a diagnosis of sepsis were selected based on the internationally recognized 2005 standard for childhood sepsis, the 2012 Surviving Sepsis Campaign guidelines for pediatric sepsis, and the 2015 expert consensus on sepsis criteria for Chinese children with septic shock. The age range of the patients included in the study spanned from 1 month to 16 years old
Key inclusion criteria (1 listed)
- From May 2021 to December 2024, the study focused on patients admitted to the Pediatric Intensive Care Unit (PICU) for a duration exceeding three days. Specifically, patients with severe infection and those who underwent pediatric neurosurgery were diagnosed with sepsis according to the international standard for childhood sepsis established in 2005, the 2012 Surviving Sepsis Campaign guidelines for pediatric sepsis, and the 2015 expert consensus on sepsis criteria for Chinese children with septic shock. The age range of the patients included in the study spanned from 1 month to 16 years old.
Key exclusion criteria (1 listed)
- Children who enter PICU 24 hours and die or exit PICU within 24 hours; Genetic metabolic diseases; Congenital immune deficiency; Can't sign an informed consent form.
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 |
|---|---|---|
| This study is an observational studie which have no interventionThis study is an observational studie which have no intervention | Other | Patients without sepsis In ICU, Sepsis-associated acute kidney injury |
Primary outcome
Gut microbiota
Time frame: the first three day after admission
Alterations and specific biomarkers of the intestinal microbiota in patients with sepsis complicated by acute kidney injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- 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.
Yaya Xu, M.S. study director
Shanghai Jiaotong University School of Medicine Xinhua Hospital
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 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 1 inclusion and 1 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 9 Jan 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota (time frame: the first three day after admission). 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 9 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.