An observational study in Sepsis and Infection, sponsored by Zhujiang Hospital. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Zhujiang Hospital · Observational
Among 11 studies in Sepsis by Zhujiang Hospital — 4 open to participants now, 4 under way, none of them phase 3. Sepsis · Zhujiang Hospital.
Among the 11 studies in Sepsis by Zhujiang Hospital, this one is one of 2 that started in 2026, is one of 5 observational ones, and was the 11th registered.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
Browse Sepsis studies →4 of the 11 studies in Sepsis by Zhujiang Hospital are open now, in 1 country. Recruiting first, the newest first:
Zhujiang Hospital · Sites in China
Ages 18+ · Healthy volunteers
Zhujiang Hospital · Sites in China
Ages 18–80
Zhujiang Hospital · Sites in China
Ages 18–80
By country, each count listing its studies:
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4
First in 2017; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 488 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Median enrollment 117 across the 6 interventional studies, 216 across the 5 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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Zhujiang Hospital is the lead sponsor of 202 studies on the registry; 96 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Sepsis by Zhujiang Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of this multicenter prospective observational cohort study is to determine whether plasma neprilysin can predict the development of sepsis within 48 hours in adults admitted to an intensive care unit with confirmed or suspected infection who do not have sepsis at enrollment.
The study will be conducted at Zhujiang Hospital, Southern Medical University, and Guangzhou First Municipal People's Hospital. Plasma samples remaining after routine clinical testing will be used to measure neprilysin and conventional sepsis biomarkers. Sublingual microcirculation will also be assessed when feasible.
Participants will be assessed for the development of sepsis from enrollment through 48 hours and will be followed for survival through Day 28. No treatment or clinical intervention will be assigned by the study protocol.
This is a multicenter prospective observational cohort study conducted in the intensive care units of Zhujiang Hospital, Southern Medical University, and Guangzhou First Municipal People's Hospital.
Newly admitted intensive care unit participants will be screened daily according to predefined eligibility criteria. Eligible participants with confirmed or suspected infection who do not meet the protocol-defined criteria for sepsis at enrollment will be approached consecutively. Written informed consent will be obtained from the participant or the participant's legally authorized representative before enrollment.
Day 0 is defined as the date of the first plasma sample collection. Plasma samples will be collected on Day 0 and Day 1, processed according to standardized procedures, aliquoted, stored at -80 degrees Celsius, and batch-tested for neprilysin, interleukin-6, C-reactive protein, and procalcitonin. Laboratory personnel will be blinded to clinical outcomes.
When oral conditions permit, sublingual microcirculation will be assessed on Day 0 and Day 1. Measurements will include microvascular flow index, perfused vessel density, and perfused boundary region. Image assessors will be blinded to clinical outcomes.
Sequential Organ Failure Assessment 2 scores will be evaluated at baseline, Day 1, and Day 2. Development of sepsis within 48 hours will be independently adjudicated by two investigators who are blinded to plasma neprilysin and sublingual microcirculation results. Disagreements will be resolved by a senior intensive care physician.
Receiver operating characteristic curve analysis and logistic regression will be used to evaluate plasma neprilysin alone and in combination with conventional biomarkers and sublingual microcirculation measurements. Predictive performance will be internally validated using bootstrap resampling.
Adult critically ill participants admitted to the intensive care unit of Zhujiang Hospital, Southern Medical University, with confirmed or suspected infection who do not meet the protocol-defined criteria for sepsis at enrollment. Newly admitted intensive care unit participants will be screened daily.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults admitted to the intensive care unit with confirmed or suspected infection who do not meet the protocol-defined criteria for sepsis at enrollment. Participants will be observed for the development of sepsis through 48 hours and followed for survival through Day 28.
Diagnostic Test: Plasma Neprilysin Measurement · Diagnostic Test: Conventional Sepsis Biomarker Measurement · Diagnostic Test: Sublingual Microcirculation Assessment
Plasma collected at enrollment will be tested for neprilysin using an enzyme-linked immunosorbent assay. The result will not be used to guide clinical treatment.
Plasma will be batch-tested for interleukin-6, C-reactive protein, and procalcitonin for comparison with plasma neprilysin.
Sublingual microcirculation will be assessed when oral conditions permit. Measurements will include microvascular flow index, perfused vessel density, and perfused boundary region. The results will not be used to assign treatment.
Development of sepsis within 48 hours
The reference outcome is the development of sepsis within 48 hours after enrollment. Sepsis is defined as confirmed or suspected infection with an acute increase of at least 2 points in the Sequential Organ Failure Assessment 2 score from baseline that is attributable to infection. The predictive performance of baseline plasma neprilysin will be summarized using the area under the receiver operating characteristic curve with its 95 percent confidence interval. Sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios will also be reported at the selected cutoff value.
Time frame: From enrollment through 48 hours
Predictive Performance of Plasma Neprilysin Combined With Sublingual Microcirculation Measures for Sepsis Within 48 Hours
A prediction model combining baseline plasma neprilysin, microvascular flow index, perfused vessel density, and perfused boundary region will be evaluated. Model performance will be summarized using the area under the receiver operating characteristic curve with its 95 percent confidence interval and measures of calibration.
Time frame: From enrollment through 48 hours
Comparative Predictive Performance of Plasma Neprilysin and Conventional Biomarkers for Sepsis Within 48 Hours
The predictive performance of baseline plasma neprilysin will be compared with that of interleukin-6, C-reactive protein, and procalcitonin. Areas under the receiver operating characteristic curves will be calculated with 95 percent confidence intervals and compared using the DeLong method.
Time frame: From enrollment through 48 hours
All-Cause Mortality Within 28 Days
Vital status will be determined using hospital records or telephone follow-up.
Time frame: From enrollment through Day 28
Plan to share: No
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 492 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 16 months is below that.
Counting every sponsor, half of 544 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.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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