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Microbiome and Enteric Signatures in Sepsis-associated Hepatorenal Injury

Recruitingn/aAges 18 Years - anyAllFirst Affiliated Hospital of Zhejiang University
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In plain words

What the trial is, and whether it could suit you

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 b

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: \- For Sepsis Patients: 1. Age โ‰ฅ 18 years๏ผ› 2. 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 โ‰ฅ 2 points consequent to the infection). 3. Diagnosed with sepsis within 24 hours prior to enrollment. 4. Informed consent signed by the patient or a legally authorized representative. For Healthy Volunteers: 1. Age โ‰ฅ 18 years. 2. No chronic underlying diseases (including liver, kidney, gastrointestinal, or immune-related disorders). 3. No use of antibiotics or probiotics, and no history of acute infection within 1 month prior to enrollment (to ensure baseline consistency). 4. Informed consent signed by the volunteer. Exclusion Criteria: 1. History of chronic liver disease (e.g., cirrhosis, chronic hepatitis B/C, autoimmune hepatitis, hepatic carcinoma). 2. History of chronic kidney disease (e.g., glomerulonephritis, IgA nephropathy). 3. History of inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or previous major intestinal resection. 4. Patients with malignant tumors currently receiving chemotherapy or radiotherapy. 5. Expected survival time of less than 72 hours. 6. Pregnant or lactating women. 7. Concurrent participation in other interventional clinical trials.
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What it tests

  • Not listed
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Where

6 sites
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Lin'an Traditional Chinese Medicine Hospital
Hangzhou, China
The Second Affiliated Hospital of Jiaxing University
Jiaxing, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
Enze Hospital, Taizhou Enze Medical Center (Group)
Taizhou, China
Taizhou Hospital of Zhejiang Province
Taizhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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