Effects of Immune Function on Prognositic Outcome in Critical Ill Patients With Acinetobacter Baumannii Infection

August 31, 2016 updated by: Jianfeng Xie, Southeast University, China
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who admitted into ICU and infection with Acinetobacter baumannii.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acinetobacter baumannii infection
Critically ill patients infect with Acinetobacter baumannii
Other: None intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28 day mortality
Time Frame: 28 day
28 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 27, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160826

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

we would like to share our data. Someone who need data can contact us with Email.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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