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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02886637
Other study ID # 20160826
Secondary ID
Status Completed
Phase N/A
First received August 27, 2016
Last updated August 31, 2016
Start date July 2015
Est. completion date March 2016

Study information

Verified date August 2016
Source Southeast University, China
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of the present study is to evaluate the effects of immune function on prognositic outcome in critical ill patients with Acinetobacter baumannii infection.


Description:

This is a single-center, observational study. Patients with Acinetobacter baumannii infection in the intensive care unit of Zhongda Hospital were enrolled. We recorded the data of age, ICU admission diagnosis, underlying diseases, APACHE II score and infection site. Body temperature, heart rate, white blood cell counts, procalcitonin, C-reactive protein, SOFA score and the level of CD4+, CD8+, Th1, Th2 and HLA-DR in the blood measured by flow cytometry on the D1, D3 and D7 were also recorded.We can get the results of the change of immune function of critical ill patients after Acinetobacter baumannii infection. After compare the patients who die of survive at 28 day after infection, we can get the results of the relationship between the immune function and the outcome. We also can calculate the effect immune function on prognositic mortality in patients with Acinetobacter baumannii infection.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients admitted to ICU

- Infection with Acinetobacter baumannii

- Agree to participate the study

Exclusion Criteria:

- Age less than 16 years old or older than 80 years old

- pregnancy

- immunosuppression patients which include

1. therapy 0.5mg/kg/day of prednisoneover(equivalent dose of other glucocorticoids) for at least 1 month within recent 3 month

2. Cancer chemotherapy within recent 3 month

3. Receive immunosuppression treatment because of solid organ transplant or Autoimmune diseases

4. allogeneic bone marrow transplantation or allogeneic haematopoietic stem cell transplantation.

5. HIV infection

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
None intervention


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Southeast University, China

Outcome

Type Measure Description Time frame Safety issue
Primary 28 day mortality 28 day No
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