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The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data
This study is a prospective, randomized controlled trial, which the subjects were severe sepstic patients for selecting Meropenem as antimicrobial drugs. The experimental and control group were used different administration of Meropenem through monitoring the Meropenem plasma concentration and clinical data, eventually demonstrate the effecacy and safety of Meropenem in patients with severe infection and optimize the best clinical practice for antimicrobial agents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | meropenem injection, 1.0g, q8h,intravenous infusion ,0.5g/0.5h+0.5g/4h |
|
| Control group | Other | meropenem injection, 1.0g, q8h,continuous intravenous infusion duration ,1h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem Injection | Drug | Different administration types between two groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| T>MIC | Time above MIC% per administration interval | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| APACHE II score | Change of Acute physiology and chronic health evaluation score (APACHE II score) during period of treatment | Day 0,Day 4,Day 8 |
| SOFA | Change of Sepsis-related Organ Failure Assessment score (sofa) during period of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aihua FEI | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xinhua Hospital | Shanghai | Shanghai Municipality | 200092 | China |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Day 0,Day 4,Day 8 |
| Mortality | Mortality within 28 days | Day 28 |
| highest temperature | Variation of the highest temperature | Day 0,Day 4,Day 8 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |