ClinicalTrials.gg
Enrolling by invitationNCT07811544Updated Oct 13, 2026

Immune Evaluation for Postoperative Sepsis-AKI

An observational study in Sepsis and Acute Kidney Injury, sponsored by Beijing Chao Yang Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Beijing Chao Yang Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 285 studies in Sepsis with a site in China — 98 open to participants now, 105 under way, 5 of them phase 3. Sepsis · China.

Planned enrollment
38th of 164
800 · median 180
Started
2026
with 31 others
Observational
165 of 285
51 open now
Primary completion
2028-01
later than 86 of 104 live
Registered
274th of 285
by date

Among the 285 studies in Sepsis with a site in China, this one is the 38th largest by planned enrollment of the 164 observational ones, is one of 32 that started in 2026, is one of 165 observational ones, reaches primary completion later than 86 of the 104 other live ones, and was the 274th registered.

By phase

285 studies; the count open now beside each. This study's row is marked.

Observationalthis study165 · 51 open
No phase66 · 27 open
Phase 417 · 7 open
Phase 212 · 4 open
Phase 312 · 4 open
Phase 16 · 2 open
Phase 1/24 · 2 open
Phase 2/33 · 1 open

By the year they started

First in 2004; this study’s year is marked. 32 started in 2026.

Size and results

Median enrollment 119 across the 120 interventional studies, 180 across the 164 observational. Of the 87 that completed or were terminated, 1 (1%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 285 studies in Sepsis with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Sepsis
  • Acute Kidney Injury
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to the ICU

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • Patients with active undergoing chemotherapy, radiotherapy, or targeted therapy; patients with immune diseases receiving 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
28 Days
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Derivation Cohort
  • Validation Cohort

    Other: Not applicable- observational study

Interventions

  • OtherNot applicable- observational study

    Not applicable- observational study

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From Day 1 to Day 7 after enrollment

Secondary outcomes

  1. 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.

    Time frame: From Day 1 through Day 28 after enrollment

  2. 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.

    Time frame: From ICU admission through 72 hours after ICU admission

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jan 2028, 24 months after the start.

Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 24 months is below that.

Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Sep 10, 2026
StartActual
Jan 1, 2026
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
1 added
What changed in the outcomes
  • AddedIncidence of Intra-Abdominal Hypertension After SurgeryTime frame: From ICU admission through 72 hours after ICU admission
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Secondary outcomes 1 added
    What changed in the outcomes
    • AddedIncidence of Intra-Abdominal Hypertension After SurgeryTime frame: From ICU admission through 72 hours after ICU admission

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07811544
Collaborators
Beijing Jishuitan Hospital
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Jan 1, 2026
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Oct 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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