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SepsisNCT01406951

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

An observational study of Sepsis and Ventilator-Associated Pneumonia, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Ventilator-Associated Pneumonia
How many people
92 participants
Where
1 siteChina
Study dates
Sep 2009to Mar 2011
Phase
Observational
Are there results?
None posted in the registry

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: 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.

Who may be able to join

  • (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 ).

Who cannot join

  • (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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

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.

Keywords
sTREM-1, PCT, CPIS, VAP, EVC, diagnosis, prognosis
Medical subject headings
Sepsis, Pneumonia, Ventilator-Associated, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01406951
Study groupRoleWhat they receive
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.
sepsisSIRS + 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 ).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2011 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

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
Case-control
Time perspective
Prospective
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01406951
Sponsor's protocol ID
301PLAGH-20090923001
Status last verified
Sep 2009
First submitted
29 Jul 2011
Last updated
1 Aug 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Ventilator-Associated Pneumonia, run by Chinese PLA General 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 1 Aug 2011. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Patients Outcome (time frame: 28 days). 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 1 Aug 2011.

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