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CompletedNCT01406951Updated Aug 1, 2011

Diagnostic Value of sTREM-1 and PCT Level as Well as CPIS Score for Ventilator-Associated Pneumonia Among ICU Sepsis Patients

An observational study in Sepsis and Ventilator-Associated Pneumonia, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-01.

Sponsored by Chinese PLA General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
92
Ages
18 Years and older
Sex
All
01

Study summary

Aims: to explore the value of TREM-1 (triggering receptor expressed on myeloid cells-1) ,PCT(Procalcitonin), as well as CPIS (clinical pulmonary infection score) in the diagnostic and prognostic assessment of VAP (ventilator associated pneumonia); and to make a comparison with WBC (white blood cells) and CRP (C-reactive protein) level as well as SOFA (Sequential Organ Failure Assessment) Score Methods: There were 92 subjects of sepsis, who were either receiving endotracheal intubation or had undergone tracheotomy and were exposed to mechanical ventilation. The subjects were divided into the VAP group (32) and the Non-VAP group (60), the criterion being the contraction of VAP 48 hours after ICU admission. Etiological culture was conducted in BALF (bronchoalveolar lavage fluid). And sTREM-1 density was determined by examining serum sTREM-1, PCT, WBC, CRP and EVC (exhaled ventilator condensate). Meanwhile, the CPIS and SOFA score were worked out. With a 28-day survival as the demarcation line, the VAP group was further divided into the survivors group, who stayed alive for 28 days or more , and the non-survivors group, who died within 28 days. The sTREM-1 and PCT level were denoted as meridians (range interquartile), while the WBC and CRP level as well as the CPIS and SOFA score, means±standard deviations (SD).

Results: Averagely, the patients would contract clinically-confirmed VAP 6.9 days after admission, which was mainly traced to Gram-negative bacilli infection. On the very day of diagnosis, compared with the Non-VAP group, the VAP group showed a higher level of serum sTREM-1, PCT, WBC and CRP as well as CPIS and SOFA score(295.6pg/ml vs.143.5pg/ml, P\<0.001;4.5ng/ml vs. 1.4ng/ml,P=0.008;16.7×10∧9/L vs.10.9×10∧9/L, P\<0.001;11.5mg/dl vs. 7.7mg/dl,P=0.012; 6.0vs. 1.9, P\<0.001;10.0vs. 7.5, P=0.017), AUC (area under the receiver operating characteristic curve)turned out as follows :sTREM-1: 0.73(95% CI 0.61-0.85);PCT : 0.70(95% CI 0.57-0.83);WBC: 0.73(95% CI 0.60-0.85).The CPIS score, which was proved by logistic regression analysis as the sole risky factor to VAP, amounted to 0.96(95% CI 0.91-1.00). Combined prediction probability containing all the data was calculated in accordance on the relative regression equation. sTREM-1+WBC+CPIS score proved to be most reliable for diagnosis. AUC turned out as 0.98. With 0.277 as the cut-off point, sensitivity measured 0.97, specificity, 0.9 and YDI, 0.87. There were only 5 VAP subjects whose sTREM-1 density could be detected in EVC. The VAP patients were divided into a survivors group (n=15) and a non-survivors group (n=17) with a 28-day survival as the demarcation line. The non-survivors group demonstrated a higher PCT level and higher CPIS \& SOFA score than the survivors. (3.0ng/ml vs. 15.3ng/ml,P=0.032;5.4vs. 6.6, P=0.03;8.1vs.11.7 P=0.049). AUC worked out PCT 0.752(95% CI 0.547-0.956)and CPIS 0.764(95% CI 0.575-0.953). Calculations on the regression equation showed the PCT+CPIS score was most reliable for prognostic assessment. AUC turned out as 0.848. With 0.516 as the demarcation line, sensitivity measured 0.867, specificity, 0.818 and YDI, 0.685.

conclusion: WBC + CPIS helps improve VAP diagnosis; PCT+CPIS may be used for VAP prognostic assessment. Taking two items into consideration will be of guiding value in VAP treatment as well as mortality rate reduction. The sTREM-1 level in EVC,however,may be devoid of value for VAP diagnosis.

02

Conditions studied

  • Sepsis
  • Ventilator-Associated Pneumonia

Keywords

  • sTREM-1
  • PCT
  • CPIS
  • VAP
  • EVC
  • diagnosis
  • prognosis
03

In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's enrollment of 92 is below the median of 160 across 957 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 568 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All subjects were selected from among inpatients who were hospitalized between March 2010 and March 2011 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

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

  • (1)Male and female aged 18 years old and over;
  • (2)Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.(3)Clinically suspected infection; (4)Fulfilled criteria of VAP diagnosis(a) after 48-72h endotracheal intubation, X-ray film displays new or progressive infiltrating focus; (b)The patient is in two of the following conditions: a. fever (temperature >38 ℃ or higher than basal temperature; b. peripheral WBC count≥10×10∧9/L,or \<4×10∧9/L; c. appearance or increase of purulent respiratory tract secretion. Besides the diagnostic norms above, it is suggested that lower respiratory tract secretions be collected under the bronchoscope and half-quantitative etiological culture be carried out through the medium of BALF samples (diagnostic threshold value:104cfu/mL ).

Exclusion criteria

Exclusion Criteria:

  • (1) were under 18 years of age;
  • (2) had contracted VAP upon ICU admission or in less than 48h after being admitted;
  • (3) were suffering from acquired immunodeficiency syndrome;
  • (4)were suffering from polymorphonuclear granulocyte counts (\< 500 μL-1); - (5) died within 24h after being taken into the ICU, or refused to get involved in the study, or gave up treatment during the period of observation
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
92 participants (actual)

Groups and cohorts

  • SIRS

    (1) temperature \> 38oC or \< 36oC; (2) pulse rate \> 90 beats/min; (3) ventilation rate \> 20 breaths/min or hyperventilation with a partial pressure of arterial carbon dioxide (PaCO2) \< 32 mmHg; (4) white blood cell (WBC) count \>1 2,000μL-1 or \< 4000 μL-1 , or \> 10% immature cells.

  • sepsis

    SIRS + infection

  • VAP

    (1) after 48-72h endotracheal intubation, X-ray film displays new or progressive infiltrating focus; (2)The patient is in two of the following conditions: a. fever (temperature \>38 ℃ or higher than basal temperature; b. peripheral WBC count≥10×10∧9/L,or \<4×10∧9/L; c. appearance or increase of purulent respiratory tract secretion. Besides the diagnostic norms above, it is suggested that lower respiratory tract secretions be collected under the bronchoscope and half-quantitative etiological culture be carried out through the medium of BALF samples (diagnostic threshold value:104cfu/mL ).

06

What researchers measure

Primary outcomes

  1. Patients Outcome

    The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death

    Time frame: 28 days

07

Study locations

1 site
  • Chinese PLA General Hospital
    Beijing, Beijing Municipality 100853, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Mar 2011 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.

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

Registered
Jul 29, 2011
First posted
Aug 1, 2011
Start
Sep 2009
Primary completionActual
Mar 2011
CompletionActual
Mar 2011
Last update
Aug 1, 2011
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.
No changes since tracking began. The registry record was last updated on Aug 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01406951
First posted
Aug 1, 2011
Start date
Sep 2009
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Aug 1, 2011

Study contacts

Xie Lixin, doctor
study director · Department Of Respiratory Diseases, Chinese PLA General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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