SepsisMESHNCT07735182
Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury
An observational study of Sepsis and Acute Kidney Injury Due to Sepsis, run by First Affiliated Hospital of Zhejiang University at 6 sites in China.
Trial summary
Sepsis is a major cause of morbidity and mortality in intensive care units. Sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) are common complications associated with adverse clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Acute Kidney Injury Due to Sepsis, Gastrointestinal Microbiome
- How many people
- 1,000 participants
- Where
- 6 sitesChina
- Study dates
- 15 Feb 2026to 15 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprises two distinct groups recruited from multiple clinical centers. The primary clinical cohort consists of critically ill adult patients (aged ≥18 years) admitted to the Intensive Care Unit (ICU) who are diagnosed with sepsis according to the Sepsis-3 criteria and enrolled within 24 hours after sepsis diagnosis. This cohort will be longitudinally monitored to evaluate changes in the gut microbiome, the occurrence of sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) from Day 0 through Day 7 after sepsis diagnosis, and subsequent organ recovery status at Days 14-20 among patients who develop SALI and/or S-AKI. A baseline reference cohort consists of healthy adult volunteers recruited from the community. These volunteers have no history of chronic underlying diseases or recent antibiotic/probiotic use and serve to establish baseline reference profiles for the gut microbiome and circulating metabolites.
Who may be able to join
- -
- For Sepsis Patients:
- Age ≥ 18 years；
- Admitted to the Intensive Care Unit (ICU) and meets the Sepsis-3 diagnostic criteria (an acute change in total Sequential Organ Failure Assessment [SOFA] score ≥ 2 points consequent to the infection).
- Diagnosed with sepsis within 24 hours prior to enrollment.
- Informed consent signed by the patient or a legally authorized representative.
Show all 11Show fewer
- For Healthy Volunteers:
- Age ≥ 18 years.
- No chronic underlying diseases (including liver, kidney, gastrointestinal, or immune-related disorders).
- No use of antibiotics or probiotics, and no history of acute infection within 1 month prior to enrollment (to ensure baseline consistency).
- Informed consent signed by the volunteer.
Who cannot join
- History of chronic liver disease (e.g., cirrhosis, chronic hepatitis B/C, autoimmune hepatitis, hepatic carcinoma).
- History of chronic kidney disease (e.g., glomerulonephritis, IgA nephropathy).
- History of inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or previous major intestinal resection.
- Patients with malignant tumors currently receiving chemotherapy or radiotherapy.
- Expected survival time of less than 72 hours.
- Pregnant or lactating women.
- Concurrent participation in other interventional clinical trials.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Wenqiao Yu, PhD, +86-18868787588, yuwenqiao1980@zju.edu.cn
Wenqiao Yu, PhD, yuwenqiao1980@zju.edu.cn
- Recruiting
Lin'an Traditional Chinese Medicine Hospital
Hangzhou, Zhejiang
Jun Chen, +86-13989885492, chenj29@126.com
- Recruiting
The Second Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang
Jiansheng Zhang, +86-18358375756, 1355698631@qq.com
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Zhouzhou Dong, PhD, +86-13858287868, lhldongzhouzhou@nbu.edu.cn
- Recruiting
Enze Hospital, Taizhou Enze Medical Center (Group)
Taizhou, Zhejiang
Lu Zhang, +86-18868151013, zhangl5828@enzemed.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Min Mao, PhD, +86-17857062036, 15228291365@163.com
About this study
Official title: The Association of Gut Microbiota With Sepsis-Associated Acute Hepatorenal Injury: A Prospective, Multicenter, Observational Study
Sepsis is a major cause of morbidity and mortality in intensive care units. Sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) are common complications associated with adverse clinical outcomes. Altered gut microbial diversity, microbial metabolites, intestinal barrier dysfunction, and systemic inflammation may contribute to hepato-renal injury during sepsis. However, prospective longitudinal evidence in patients with SALI and S-AKI remains limited.
This prospective, multicenter, longitudinal observational cohort study will enroll adult patients with sepsis across eight intensive care units at six medical centers and healthy adult volunteers as a baseline reference cohort. For patients with sepsis, stool and blood samples will be collected on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis. Healthy volunteers will provide a single baseline stool and blood sample at enrollment. Fecal microbial alpha diversity and community structure will be assessed by metagenomic sequencing and bioinformatic analysis. Plasma metabolites, including total short-chain fatty acids, indoxyl sulfate, and additional targeted plasma metabolites, will be measured by ultra-high-performance liquid chromatography-tandem mass spectrometry. Intestinal barrier and clinical biomarkers will also be assessed.
The primary objectives are to evaluate the associations between longitudinal trajectories of fecal microbial alpha diversity, measured by the Shannon diversity index, and the occurrence of SALI and S-AKI within 7 days after sepsis diagnosis. Secondary objectives include evaluating the associations between longitudinal changes in fecal microbial beta diversity and the occurrence of SALI and S-AKI; assessing the associations between longitudinal trajectories of fecal microbial alpha diversity and organ recovery status at Days 14-20 among patients who develop SALI or S-AKI; describing selected plasma metabolite and intestinal biomarker concentrations at prespecified time points; and assessing 28-day all-cause mortality. Exploratory multi-omics analyses will evaluate microbial taxa, microbial functional genes, metabolites, and host biomarkers to identify candidate biomarkers and biological pathways associated with the development and clinical course of sepsis-associated hepato-renal injury.
- Conditions
- Sepsis, Acute Kidney Injury Due to Sepsis, Gastrointestinal Microbiome, Sepsis-Associated Liver Injury, Intensive Care Medicine
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Patients | Adult patients (age ≥18 years) admitted to the ICU who meet the Sepsis-3 diagnostic criteria are enrolled within 24 hours after sepsis diagnosis. This cohort will be longitudinally monitored with biospecimen collection at four time points (Day 0, Days 3-5, Days 7-10, and Days 14-20). Based on clinical progression from Day 0 through Day 7 after sepsis diagnosis, participants will be classified according to the presence or absence of sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) for outcome-specific comparative analyses. Participants with neither SALI nor S-AKI will constitute the Sepsis Control subgroup. Participants meeting criteria for both SALI and S-AKI will be included in both outcome-specific analyses. Among participants who develop SALI and/or S-AKI, organ recovery status will also be evaluated at Days 14-20 after sepsis diagnosis. | |
| Healthy Volunteers | Healthy adult volunteers (age ≥ 18 years) without chronic underlying diseases (e.g., liver, kidney, or gastrointestinal disorders) and no history of antibiotic or probiotic use within the past month. This cohort serves as a baseline reference cohort to characterize reference gut microbial and metabolic profiles; biospecimens will be collected only once at the time of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of Longitudinal Trajectories in Fecal Microbial Alpha Diversity With the Occurrence of Sepsis-Associated Acute Kidney Injury
Sepsis-associated acute kidney injury (S-AKI) occurring from Day 0 through Day 7 after sepsis diagnosis will be assessed according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria using serum creatinine and urine output obtained from routine clinical laboratory testing and medical records. Fecal microbial alpha diversity will be measured using the Shannon diversity index (unitless), calculated from metagenomic sequencing and bioinformatic analysis of stool samples collected on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis. Longitudinal trajectories of the Shannon diversity index will be compared between patients with and without S-AKI using linear mixed-effects models accounting for repeated measurements within participants. The primary longitudinal association will be evaluated using the group-by-time interaction term.
Measured: Fecal microbial alpha diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; S-AKI assessed from Day 0 through Day 7 after sepsis diagnosis.
Association of Longitudinal Trajectories in Fecal Microbial Alpha Diversity With the Occurrence of Sepsis-Associated Liver Injury
Sepsis-associated liver injury (SALI) occurring from Day 0 through Day 7 after sepsis diagnosis will be assessed using routine clinical laboratory measurements. SALI is defined by at least one of the following: total bilirubin (TBIL) >2 mg/dL and international normalized ratio (INR) >1.5; alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN); alkaline phosphatase (ALP) ≥2 times ULN; or ALT ≥3 times ULN with TBIL ≥2 times ULN. Fecal microbial alpha diversity will be measured using the Shannon diversity index (unitless), calculated from metagenomic sequencing and bioinformatic analysis of stool samples collected on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis. Longitudinal trajectories of the Shannon diversity index will be compared between patients with and without SALI using linear mixed-effects models accounting for repeated measurements within participants. The group-by-time interaction will represent the longitudinal association.
Measured: Fecal microbial alpha diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; SALI assessed from Day 0 through Day 7 after sepsis diagnosis.
Secondary outcomes (8)
Association of Longitudinal Changes in Fecal Microbial Beta Diversity With the Occurrence of Sepsis-Associated Acute Kidney Injury
Sepsis-associated acute kidney injury (S-AKI) occurring from Day 0 through Day 7 after sepsis diagnosis will be defined according to KDIGO criteria using serum creatinine and urine output. Fecal microbial beta diversity will be assessed using Bray-Curtis dissimilarity (unitless) from metagenomic sequencing of stool samples collected on Day 0, Days 3-5, Days 7-10, and Days 14-20. Longitudinal differences in microbial community composition between patients with and without S-AKI will be evaluated using PERMANOVA including group, time, and group-by-time interaction, with repeated measurements accounted for by constrained permutations. The longitudinal association will be reported as the PERMANOVA R² for the group-by-time interaction.
Measured: Fecal microbial beta diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; S-AKI assessed from Day 0 through Day 7 after sepsis diagnosis.
Association of Longitudinal Changes in Fecal Microbial Beta Diversity With the Occurrence of Sepsis-Associated Liver Injury
Sepsis-associated liver injury (SALI) occurring from Day 0 through Day 7 after sepsis diagnosis will be assessed according to the prespecified SALI criteria. Fecal microbial beta diversity will be assessed using Bray-Curtis dissimilarity (unitless) from metagenomic sequencing of stool samples collected on Day 0, Days 3-5, Days 7-10, and Days 14-20. Longitudinal differences in microbial community composition between patients with and without SALI will be evaluated using PERMANOVA including group, time, and group-by-time interaction, with repeated measurements accounted for by constrained permutations. The longitudinal association will be reported as the PERMANOVA R² for the group-by-time interaction.
Measured: Fecal microbial beta diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; SALI assessed from Day 0 through Day 7 after sepsis diagnosis.
Association of Longitudinal Trajectories in Fecal Microbial Alpha Diversity With Kidney Recovery Status After Sepsis-Associated Acute Kidney Injury
Among patients who develop sepsis-associated acute kidney injury (S-AKI) from Day 0 through Day 7 after sepsis diagnosis, kidney recovery status will be assessed at Days 14-20 relative to baseline serum creatinine. Complete recovery will be defined as serum creatinine <1.2 times baseline without ongoing kidney replacement therapy (KRT); partial recovery as serum creatinine ≥1.2 but <1.5 times baseline without ongoing KRT; and non-recovery as serum creatinine ≥1.5 times baseline or ongoing KRT. Fecal microbial alpha diversity will be measured using the Shannon diversity index at the four prespecified time points. Longitudinal trajectories will be compared across kidney recovery categories using linear mixed-effects models accounting for repeated measurements within participants.
Measured: Fecal microbial alpha diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; kidney recovery status assessed at Days 14-20.
Association of Longitudinal Trajectories in Fecal Microbial Alpha Diversity With Liver Injury Recovery Status After Sepsis-Associated Liver Injury
Among patients who develop sepsis-associated liver injury (SALI) from Day 0 through Day 7 after sepsis diagnosis, liver injury recovery status will be assessed at Days 14-20 using the prespecified SALI criteria. Recovery will be defined as no longer meeting any SALI criterion; persistent liver injury will be defined as meeting at least one SALI criterion at Days 14-20. Fecal microbial alpha diversity will be measured using the Shannon diversity index at the four prespecified time points. Longitudinal trajectories will be compared between patients with liver injury recovery and those with persistent liver injury using linear mixed-effects models accounting for repeated measurements within participants.
Measured: Fecal microbial alpha diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; liver injury recovery status assessed at Days 14-20.
Total Plasma Short-Chain Fatty Acid Concentration
Total plasma short-chain fatty acid concentration will be reported as a single aggregate value at each prespecified time point. It will be calculated as the sum of plasma acetate, propionate, and butyrate concentrations, all measured in μmol/L by ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS).
Measured: Days 0, 3-5, 7-10, and 14-20 after sepsis diagnosis.
Plasma Indoxyl Sulfate Concentration
Plasma indoxyl sulfate concentration will be measured by UPLC-MS/MS and reported in μmol/L at each prespecified time point.
Measured: Days 0, 3-5, 7-10, and 14-20 after sepsis diagnosis.
Fecal Calprotectin Concentration
Fecal calprotectin concentration will be measured using a validated fecal calprotectin immunoassay and reported in μg/g of stool at each prespecified time point.
Measured: Days 0, 3-5, 7-10, and 14-20 after sepsis diagnosis.
28-Day All-Cause Mortality
All-cause mortality within 28 days after sepsis diagnosis, reported as the percentage (%) of enrolled sepsis patients who die. Vital status will be ascertained from medical records and follow-up contact.
Measured: Day 28 after sepsis diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Feb 2026
- Primary completion14 Feb 2030 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Taizhou Enze Medical Center Group, The Second Affiliated Hospital of Jiaxing University, Lin'an Traditional Chinese Medicine Hospital, Ningbo Medical Center Lihuili Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735182
- Sponsor's protocol ID
- IIT20260155B-R2
- Acronym
- MESH
- Status last verified
- Feb 2026
- First submitted
- 15 Jul 2026
- Last updated
- 7 Oct 2026
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Gut Microbiota With Sepsis-Associated Acute Hepatorenal Injury: A Prospective, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT07735182
- Acronym / sponsor ID
- MESH / IIT20260155B-R2
- Conditions
- Sepsis, Acute Kidney Injury Due to Sepsis, Gastrointestinal Microbiome, Sepsis-Associated Liver Injury, Intensive Care Medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Taizhou Enze Medical Center Group, The Second Affiliated Hospital of Jiaxing University, Lin'an Traditional Chinese Medicine Hospital, Ningbo Medical Center Lihuili Hospital
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 14 Feb 2030 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 29 Jul 2026 (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.
Sepsis is a major cause of morbidity and mortality in intensive care units. Sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) are common complications associated with adverse clinical outcomes. Altered gut microbial diversity, microbial metabolites, intestinal barrier dysfunction, and systemic inflammation may contribute to hepato-renal injury during sepsis. However, prospective longitudinal evidence in patients with SALI and S-AKI remains limited.
This prospective, multicenter, longitudinal observational cohort study will enroll adult patients with sepsis across eight intensive care units at six medical centers and healthy adult volunteers as a baseline reference cohort. For patients with sepsis, stool and blood samples will be collected on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis. Healthy volunteers will provide a single baseline stool and blood sample at enrollment. Fecal microbial alpha diversity and community structure will be assessed by metagenomic sequencing and bioinformatic analysis. Plasma metabolites, including total short-chain fatty acids, indoxyl sulfate, and additional targeted plasma metabolites, will be measured by ultra-high-performance liquid chromatography-tandem mass spectrometry. Intestinal barrier and clinical biomarkers will also be assessed.
The primary objectives are to evaluate the associations between longitudinal trajectories of fecal microbial alpha diversity, measured by the Shannon diversity index, and the occurrence of SALI and S-AKI within 7 days after sepsis diagnosis. Secondary objectives include evaluating the associations between longitudinal changes in fecal microbial beta diversity and the occurrence of SALI and S-AKI; assessing the associations between longitudinal trajectories of fecal microbial alpha diversity and organ recovery status at Days 14-20 among patients who develop SALI or S-AKI; describing selected plasma metabolite and intestinal biomarker concentrations at prespecified time points; and assessing 28-day all-cause mortality. Exploratory multi-omics analyses will evaluate microbial taxa, microbial functional genes, metabolites, and host biomarkers to identify candidate biomarkers and biological pathways associated with the development and clinical course of sepsis-associated hepato-renal injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis Patients | – | –Adult patients (age ≥18 years) admitted to the ICU who meet the Sepsis-3 diagnostic criteria are enrolled within 24 hours after sepsis diagnosis. This cohort will be longitudinally monitored with biospecimen collection at four time points (Day 0, Days 3-5, Days 7-10, and Days 14-20). Based on clinical progression from Day 0 through Day 7 after sepsis diagnosis, participants will be classified according to the presence or absence of sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) for outcome-specific comparative analyses. Participants with neither SALI nor S-AKI will constitute the Sepsis Control subgroup. Participants meeting criteria for both SALI and S-AKI will be included in both outcome-specific analyses. Among participants who develop SALI and/or S-AKI, organ recovery status will also be evaluated at Days 14-20 after sepsis diagnosis. |
| Healthy Volunteers | – | –Healthy adult volunteers (age ≥ 18 years) without chronic underlying diseases (e.g., liver, kidney, or gastrointestinal disorders) and no history of antibiotic or probiotic use within the past month. This cohort serves as a baseline reference cohort to characterize reference gut microbial and metabolic profiles; biospecimens will be collected only once at the time of enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises two distinct groups recruited from multiple clinical centers. The primary clinical cohort consists of critically ill adult patients (aged ≥18 years) admitted to the Intensive Care Unit (ICU) who are diagnosed with sepsis according to the Sepsis-3 criteria and enrolled within 24 hours after sepsis diagnosis. This cohort will be longitudinally monitored to evaluate changes in the gut microbiome, the occurrence of sepsis-associated liver injury (SALI) and sepsis-associated acute kidney injury (S-AKI) from Day 0 through Day 7 after sepsis diagnosis, and subsequent organ recovery status at Days 14-20 among patients who develop SALI and/or S-AKI. A baseline reference cohort consists of healthy adult volunteers recruited from the community. These volunteers have no history of chronic underlying diseases or recent antibiotic/probiotic use and serve to establish baseline reference profiles for the gut microbiome and circulating metabolites.
Key inclusion criteria (11 listed)
- -
- Age ≥ 18 years；
- Admitted to the Intensive Care Unit (ICU) and meets the Sepsis-3 diagnostic criteria (an acute change in total Sequential Organ Failure Assessment [SOFA] score ≥ 2 points consequent to the infection).
- Diagnosed with sepsis within 24 hours prior to enrollment.
- Informed consent signed by the patient or a legally authorized representative.
Key exclusion criteria (7 listed)
- History of chronic liver disease (e.g., cirrhosis, chronic hepatitis B/C, autoimmune hepatitis, hepatic carcinoma).
- History of chronic kidney disease (e.g., glomerulonephritis, IgA nephropathy).
- History of inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or previous major intestinal resection.
- Patients with malignant tumors currently receiving chemotherapy or radiotherapy.
- Expected survival time of less than 72 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of Longitudinal Trajectories in Fecal Microbial Alpha Diversity With the Occurrence of Sepsis-Associated Acute Kidney Injury
Time frame: Fecal microbial alpha diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; S-AKI assessed from Day 0 through Day 7 after sepsis diagnosis.
Sepsis-associated acute kidney injury (S-AKI) occurring from Day 0 through Day 7 after sepsis diagnosis will be assessed according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria using serum creatinine and urine output obtained from routine clinical laboratory testing and medical records. Fecal microbial alpha diversity will be measured using the Shannon diversity index (unitless), calculated from metagenomic sequencing and bioinformatic analysis of stool samples collected on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis. Longitudinal trajectories of the Shannon diversity index will be compared between patients with and without S-AKI using linear mixed-effects models accounting for repeated measurements within participants. The primary longitudinal association will be evaluated using the group-by-time interaction term.
Association of Longitudinal Trajectories in Fecal Microbial Alpha Diversity With the Occurrence of Sepsis-Associated Liver Injury
Time frame: Fecal microbial alpha diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; SALI assessed from Day 0 through Day 7 after sepsis diagnosis.
Sepsis-associated liver injury (SALI) occurring from Day 0 through Day 7 after sepsis diagnosis will be assessed using routine clinical laboratory measurements. SALI is defined by at least one of the following: total bilirubin (TBIL) >2 mg/dL and international normalized ratio (INR) >1.5; alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN); alkaline phosphatase (ALP) ≥2 times ULN; or ALT ≥3 times ULN with TBIL ≥2 times ULN. Fecal microbial alpha diversity will be measured using the Shannon diversity index (unitless), calculated from metagenomic sequencing and bioinformatic analysis of stool samples collected on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis. Longitudinal trajectories of the Shannon diversity index will be compared between patients with and without SALI using linear mixed-effects models accounting for repeated measurements within participants. The group-by-time interaction will represent the longitudinal association.
8 secondary outcomes
Association of Longitudinal Changes in Fecal Microbial Beta Diversity With the Occurrence of Sepsis-Associated Acute Kidney Injury
Time frame: Fecal microbial beta diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; S-AKI assessed from Day 0 through Day 7 after sepsis diagnosis.
Association of Longitudinal Changes in Fecal Microbial Beta Diversity With the Occurrence of Sepsis-Associated Liver Injury
Time frame: Fecal microbial beta diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; SALI assessed from Day 0 through Day 7 after sepsis diagnosis.
Association of Longitudinal Trajectories in Fecal Microbial Alpha Diversity With Kidney Recovery Status After Sepsis-Associated Acute Kidney Injury
Time frame: Fecal microbial alpha diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; kidney recovery status assessed at Days 14-20.
Association of Longitudinal Trajectories in Fecal Microbial Alpha Diversity With Liver Injury Recovery Status After Sepsis-Associated Liver Injury
Time frame: Fecal microbial alpha diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; liver injury recovery status assessed at Days 14-20.
Total Plasma Short-Chain Fatty Acid Concentration
Time frame: Days 0, 3-5, 7-10, and 14-20 after sepsis diagnosis.
Plasma Indoxyl Sulfate Concentration
Time frame: Days 0, 3-5, 7-10, and 14-20 after sepsis diagnosis.
Fecal Calprotectin Concentration
Time frame: Days 0, 3-5, 7-10, and 14-20 after sepsis diagnosis.
28-Day All-Cause Mortality
Time frame: Day 28 after sepsis diagnosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Acute Kidney Injury Due to Sepsis, run by First Affiliated Hospital of Zhejiang University at 6 sites 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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenqiao Yu, PhD (+86-18868787588, yuwenqiao1980@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of Longitudinal Trajectories in Fecal Microbial Alpha Diversity With the Occurrence of Sepsis-Associated Acute Kidney Injury (time frame: Fecal microbial alpha diversity assessed on Day 0, Days 3-5, Days 7-10, and Days 14-20 after sepsis diagnosis; S-AKI assessed from Day 0 through Day 7 after sepsis diagnosis.). The study lists 2 primary outcomes in all. 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 7 Oct 2026.