SepsisNCT07811544
Immune Evaluation for Postoperative Sepsis-AKI
An observational study of Sepsis and Acute Kidney Injury, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
This prospective, multicenter, observational cohort study plans to enroll over 800 patients with postoperative sepsis from the ICUs of two tertiary hospitals in Beijing. The study will establish a clinical database and biobank for sepsis-associated acute kidney injury (SA-AKI), characterize clinical and immune… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Acute Kidney Injury
- What is being tested?
- Not applicable- observational study
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to Jan 2028
- How long will I take part?
- 28 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU
Who may be able to join
- Age ≥ 18 years;
- Admitted to the ICU due to clinical necessity after surgical procedure;
- Expected ICU length of stay > 48 hours;
- Sepsis diagnosed according to the Sepsis-3.0 criteria;
- Patient or legally authorized representative is able to understand the study protocol, willing to participate, and provides written informed consent.
Who cannot join
- Patients with active malignancy undergoing chemotherapy, radiotherapy, or targeted therapy; patients with immune diseases receiving immunosuppressive or targeted agents; or patients who developed neutropenia/lymphopenia prior to sepsis onset due to hematologic disorders or receipt of immunosuppressive therapy;
- Patients in a moribund state with no resuscitative intent; patients with do-not-resuscitate (DNR) or withdrawal-of-care orders;
- Patients who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of an Immune Evaluation System for Postoperative Sepsis-Associated Acute Kidney Injury
This prospective, multicenter, observational cohort study plans to enroll over 800 patients with postoperative sepsis from the ICUs of two tertiary hospitals in Beijing. The study will establish a clinical database and biobank for sepsis-associated acute kidney injury (SA-AKI), characterize clinical and immune phenotypes, and develop an immune evaluation system. Using multi-omics and single-cell sequencing, we aim to identify novel immune biomarker panels and explore early warning and risk-stratification strategies based on immune profiling.
- Conditions
- Sepsis, Acute Kidney Injury
- Being tested
- Not applicable- observational study
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| Derivation Cohort | Not described | |
| Validation Cohort | Not described Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI within 7 days after ICU admission
AKI incidence is calculated as the number of patients who develop AKI divided by the total number of enrolled patients. AKI will be diagnosed and staged according to KDIGO 2012 criteria, based on serum creatinine and urine output measurements.
Measured: From Day 1 to Day 7 after enrollment
Secondary outcomes (2)
28-Day All-Cause Mortality After Enrollment
All-cause mortality within 28 days after enrollment, calculated as the number of patients who die during Days 1-28 divided by the total number of enrolled patients. Vital status will be ascertained through medical records or follow-up telephone calls.
Measured: From Day 1 through Day 28 after enrollment
Incidence of Intra-Abdominal Hypertension After Surgery
Intra-abdominal hypertension (IAH) is defined as a sustained or repeated pathological elevation in intra-abdominal pressure (IAP) ≥12 mmHg. IAP will be measured via the intravesical (bladder pressure) technique with the patient in the supine position at end-expiration, using no more than 25 mL of sterile saline instilled into the bladder, with the zero reference at the mid-axillary line at the level of the iliac crest, in accordance with WSACS recommendations. IAH incidence will be calculated as the number of patients with at least one documented IAP ≥12 mmHg during the first 72 hours after ICU admission divided by the total number of enrolled patients with available IAP measurements.
Measured: From ICU admission through 72 hours after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (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.
- 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
- 800 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jishuitan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811544
- Sponsor's protocol ID
- 2026Postoperative SA-AKI
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2026
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Immune Evaluation System for Postoperative Sepsis-Associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07811544
- Acronym / sponsor ID
- 2026Postoperative SA-AKI
- Conditions
- Sepsis, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Beijing Jishuitan Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Sep 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.
This prospective, multicenter, observational cohort study plans to enroll over 800 patients with postoperative sepsis from the ICUs of two tertiary hospitals in Beijing. The study will establish a clinical database and biobank for sepsis-associated acute kidney injury (SA-AKI), characterize clinical and immune phenotypes, and develop an immune evaluation system. Using multi-omics and single-cell sequencing, we aim to identify novel immune biomarker panels and explore early warning and risk-stratification strategies based on immune profiling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation Cohort | – | – |
| Validation Cohort | – | Other: Not applicable- observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- Admitted to the ICU due to clinical necessity after surgical procedure;
- Expected ICU length of stay > 48 hours;
- Sepsis diagnosed according to the Sepsis-3.0 criteria;
- Patient or legally authorized representative is able to understand the study protocol, willing to participate, and provides written informed consent.
Key exclusion criteria (3 listed)
- Patients with active malignancy undergoing chemotherapy, radiotherapy, or targeted therapy; patients with immune diseases receiving immunosuppressive or targeted agents; or patients who developed neutropenia/lymphopenia prior to sepsis onset due to hematologic disorders or receipt of immunosuppressive therapy;
- Patients in a moribund state with no resuscitative intent; patients with do-not-resuscitate (DNR) or withdrawal-of-care orders;
- Patients who do not meet the inclusion criteria.
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 |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | Validation Cohort |
Primary outcome
Incidence of AKI within 7 days after ICU admission
Time frame: From Day 1 to Day 7 after enrollment
AKI incidence is calculated as the number of patients who develop AKI divided by the total number of enrolled patients. AKI will be diagnosed and staged according to KDIGO 2012 criteria, based on serum creatinine and urine output measurements.
2 secondary outcomes
28-Day All-Cause Mortality After Enrollment
Time frame: From Day 1 through Day 28 after enrollment
Incidence of Intra-Abdominal Hypertension After Surgery
Time frame: From ICU admission through 72 hours after ICU admission
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 13 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sepsis and Acute Kidney Injury, run by Beijing Chao Yang Hospital 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 5 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: enrolling by invitation, as of the sponsor's last update on 13 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 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?
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?
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?
Incidence of AKI within 7 days after ICU admission (time frame: From Day 1 to Day 7 after enrollment). 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 13 Oct 2026.