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| ID | Type | Description | Link |
|---|---|---|---|
| R24TW007988 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Fogarty International Center of the National Institute of Health | NIH |
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This study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis with hypotension in Zambia. This is a follow-up study to the Simplified Severe Sepsis Protocol (SSSP) study. The intervention protocol consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. It is hypothesized that the protocol will significantly decrease in-hospital mortality in patients with severe sepsis and hypotension.
In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. In sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Studies of fluid interventions in the region, however, have demonstrated conflicting results. Outcomes in septic patients may be further affected by delays in the diagnosis of tuberculosis-associated severe sepsis.
The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis with hypotensionor septic shock, (2) To evaluate the cost of implementation for a simplified severe sepsis protocol, (3) To develop a clinical diagnostic score for identifying tuberculosis in HIV positive patients with severe sepsis, and (4) To assess the performance of the Xpert TB/RIF rapid PCR system and urine lipoarabinomannan assay for diagnosing tuberculosis in HIV positive patients with severe sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Patients are managed according to admitting doctors' orders. Blood cultures are drawn in all patients. Antibiotics are specified by the admitting doctors. |
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| Simplified Severe Sepsis Protocol | Experimental | This protocol consists of an early aggressive fluid strategy, early blood cultures and antibiotics, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings. Antibiotics are specified by the admitting doctors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplified severe sepsis protocol | Other | This protocol consists of an early aggressive fluid strategy, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings. |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital all cause mortality | During hospitalization, expected average 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality | 28-day | |
| In-hospital all cause mortality adjusted for illness severity | Adjusted for SAPS3 score | During hospitalization, expected average 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin L Andrews, MD | Vanderbilt University and University of Zambia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Teaching Hospital | Lusaka | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28973227 | Derived | Andrews B, Semler MW, Muchemwa L, Kelly P, Lakhi S, Heimburger DC, Mabula C, Bwalya M, Bernard GR. Effect of an Early Resuscitation Protocol on In-hospital Mortality Among Adults With Sepsis and Hypotension: A Randomized Clinical Trial. JAMA. 2017 Oct 3;318(13):1233-1240. doi: 10.1001/jama.2017.10913. |
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Requests for data sharing should be directed to PI. PI will then confer with Zambian co-PI to confirm that data sharing is allowable by Zambian law.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Usual care | Other | Patients are managed according to admitting doctors' orders |
|
| 28-day all cause mortality adjusted for baseline illness severity | Adjusted for SAPS3 score | 28-day |
| Cumulative adverse events | A composite outcome consisting of dopamine extravasation, dopamine-associated tissue ischemia or necrosis, iatrogenic pulmonary oedema, and transfusion-related adverse events. | During hospitalization, expected average 14 days |
| Treatment cost per patient | A budget impact analysis will determine the cost of treatment per patient using a mix of direct measurements and micro-cost observation. | During hospitalization, expected average 14 days |
| Antibiotic changed due to culture results | The proportion of patients whose antibiotic regimen was changed due to information obtained from blood culture results. | During hospitalization, expected average 14 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |