A Phase 4 interventional study of blood sample collection and Midazolam in Inflammatory Disorder of Immune System and Sepsis, sponsored by Xiangya Hospital of Central South University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-05-09.
Sponsored by Xiangya Hospital of Central South University · Phase 4, Interventional, and Treatment
ICU patients always experience all kinds of pain, discomfort and sleep disturbance,especially the sepsis patients. Appropriate sedation and analgesia is must,the newest sepsis guideline strongly recommend that mechanically ventilated sepsis patients need sedation therapy.
Recent studies show than immune dysfunction dose have an important effect on the occurrence and development of sepsis. When the body suffer from the pathogenic microorganism attacking and sepsis, it activate the systemic inflammatory response (SIRS) and compensatory anti-inflammatory response syndrome (CARS). When it is out of balance between SIRS and CARS, the inflammatory response, immune paralysis or immune dysfunction occurs and the mixed anti-inflammatory response syndrome (MARS) exists, and then the multiple organ dysfunction. So, immune dysfunction is thought to be the key factors on the development of the sepsis. Some studies show that the sedation drug such as midazolam, propofol, dexmedetomidine could suppress the inflammatory response effectively and then modulate the immune function.
Several recent studies show that midazolam has the immunoregulation effect and trend of suppress the inflammatory response, but the result is controversy, the possibly reason is the different immune status. Now there is the guideline about the different immune status: the normal immune function means that the value of mHLA-DR is more than 15000 monoclonal antibody; moderate-sever immune suppression means that the value of mHLA-DR is in the range of 5000 and 15000 monoclonal antibody; the immune paralysis means that the value of mHLA-DR is less than 5000 monoclonal antibody.
The purpose of the study is to explore the effect of midazolam to inflammatory response and organ function at mechanically ventilated sepsis patients who have different immune status.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 80 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The value of monocyte human leukocyte antigen-DR (mHLA-DR) is equal to or more than 15000 monoclonal antibody.
Other: blood sample collection · Drug: Midazolam · Drug: Morphine · Procedure: Sedation interruption
The value of mHLA-DR is equal to or more than 10000 and less than 15000 monoclonal antibody.
Other: blood sample collection · Drug: Midazolam · Drug: Morphine · Procedure: Sedation interruption
The value of mHLA-DR is equal to or more than 5000 and less than 10000 monoclonal antibody.
Other: blood sample collection · Drug: Midazolam · Drug: Morphine · Procedure: Sedation interruption
The value of mHLA-DR is less than 5000 monoclonal antibody.
Other: blood sample collection · Drug: Midazolam · Drug: Morphine · Procedure: Sedation interruption
Patients were included 1 hrs later(before the study drug is administrated), 3 d and 7 d after sedation with midazolam, blood sample is collected. Flow cytometry is performed to test the mHLA-DR and according the value of mHLA-DR, assign the participant to the 4 groups as described in the arm.
The loading dose of midazolam is 0.03-0.3 mg/kg, intravenous injected slowly for 10 minutes, then 0.04-0.2 mg/kg/h for maintenance of sedation.
Also known as: Liyuexi
Morphine is the only analgesic drug that permitted to use. 2 mg morphine is given a bolus when the participant feel pain. If the pain is not alleviated, 0.4-1 mg/h morphine is maintained.
Sedation interruption is performed at 8 am every morning.
T cell subset T Helper 1
T Helper 1(TH1) are tested before sedation, 3 d and 7 d after sedation with midazolam. The test method is Flow cytometry.
Time frame: Change from baseline of T Helper 1 at 3 and 7 days.
T cell subset T Helper 2
T Helper 2(TH2) are tested before sedation, 3 d and 7 d after sedation with midazolam. The test method is Flow cytometry.
Time frame: Change from baseline of T Helper 2 at 3 and 7 days.
T cell subset Regulatory T Cell
Regulatory T Cell are tested before sedation, 3 d and 7 d after sedation with midazolam. The test method is Flow cytometry.
Time frame: Change from baseline of Regulatory T Cell at 3 and 7 days.
Interleukin-6
Levels of interleukin-6(IL-6) are tested before sedation, 3 d and 7 d after sedation with midazolam. The test method is Enzyme Linked Immunosorbent Assay（ELISA）.
Time frame: Change from baseline of Interleukin-6 at 3 and 7 days.
Interleukin-10
Levels of interleukin-10(IL-10) are tested before sedation, 3 d and 7 d after sedation with midazolam. The test method is Enzyme Linked Immunosorbent Assay（ELISA）.
Time frame: Change from baseline of Interleukin-10 at 3 and 7 days.
Tumo necrosis factor-α(TNF-α)
Levels of Tumo necrosis factor-α(TNF-α) are tested before sedation, 3 d and 7 d after sedation with midazolam. The test method is Enzyme Linked Immunosorbent Assay（ELISA）.
Time frame: Change from baseline of TNF-α at 3 and 7 days.
duration of mechanical ventilation
Time frame: from the begining of ventilation to weaning, up to 7 days.
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: up to 7 days
Mortality
Participants' mortality of 28 and 90 days is recorded, including state of survival, the date and the reason of death.
Time frame: up to 28 days
Length of ICU stay
Time frame: from ICU admmittion to discharge from ICU,up to 28 days.
Index of renal function
level of Blood Urea Nitrogen(BUN) and Creatinine(Cr).
Time frame: baseline,the 3rd and 7th day after sedation
Index of myocardial enzyme
level of Brain Natriuretic Peptide(BNP).
Time frame: baseline,the 3rd and 7th day after sedation
Index of hepatic function
level of glutamic-pyruvic transaminase(ALT),glutamic oxalacetic transaminase(AST),Total Bilirubin(Tbil).
Time frame: baseline,the 3rd and 7th day after sedation
Index of endocrine function
level of cortisol and blood glucose.
Time frame: baseline,the 3rd and 7th day after sedation
C-reaction protein
C-reaction protein(CRP)is tested before sedation, 3 d and 7 d after sedation with midazolam. The test method is Enzyme Linked Immunosorbent Assay（ELISA）.
Time frame: baseline,the 3rd and 7th day after sedation
mHLA-DR
Levels of mHLA-DR are tested before sedation, 3 d and 7 d after sedation with midazolam. The test method is Flow cytometry.
Time frame: baseline,the 3rd and 7th day after sedation
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Xiangya Hospital of Central South University