Simplified Severe Sepsis Protocol-2 (SSSP-2) in Zambia (SSSP-2)
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|ClinicalTrials.gov Identifier: NCT01663701|
Recruitment Status : Unknown
Verified August 2012 by Ben Andrews, Vanderbilt University.
Recruitment status was: Not yet recruiting
First Posted : August 13, 2012
Last Update Posted : August 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Severe Sepsis Tuberculosis||Other: Simplified severe sepsis protocol Other: Usual care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Simplified Severe Sepsis Protocol-2 (SSSP-2): A Randomized Controlled Trial of a Bundled Intervention for Severe Sepsis at the University Teaching Hospital in Zambia|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||September 2013|
Active Comparator: Usual care
Patients are managed according to admitting doctors' orders. Blood cultures are drawn in all patients. Antibiotics are specified by the admitting doctors.
Other: Usual care
Patients are managed according to admitting doctors' orders
Experimental: Simplified Severe Sepsis Protocol
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.
Other: Simplified severe sepsis protocol
This protocol consists of an early aggressive fluid strategy, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings.
- In-hospital all cause mortality [ Time Frame: During hospitalization, expected average 14 days ]
- 28-day all-cause mortality [ Time Frame: 28-day ]
- In-hospital all cause mortality adjusted for illness severity [ Time Frame: During hospitalization, expected average 14 days ]Adjusted for SAPS3 score
- 28-day all cause mortality adjusted for baseline illness severity [ Time Frame: 28-day ]Adjusted for SAPS3 score
- Cumulative adverse events [ Time Frame: During hospitalization, expected average 14 days ]A composite outcome consisting of dopamine extravasation, dopamine-associated tissue ischemia or necrosis, iatrogenic pulmonary oedema, and transfusion-related adverse events.
- Treatment cost per patient [ Time Frame: During hospitalization, expected average 14 days ]A budget impact analysis will determine the cost of treatment per patient using a mix of direct measurements and micro-cost observation.
- Antibiotic changed due to culture results [ Time Frame: During hospitalization, expected average 14 days ]The proportion of patients whose antibiotic regimen was changed due to information obtained from blood culture results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663701
|Contact: Benjamin Andrews, MDemail@example.com|
|Contact: Holly Cassellfirstname.lastname@example.org|
|University Teaching Hospital||Not yet recruiting|
|Contact: Benjamin Andrews, MD email@example.com|
|Contact: Levy Muchemwa, MBChB firstname.lastname@example.org|
|Principal Investigator: Benjamin Andrews, MD|
|Sub-Investigator: Shabir Lakhi, MBChBMMedMPH|
|Sub-Investigator: Levy Muchemwa, MBChB|
|Principal Investigator:||Benjamin L Andrews, MD||Vanderbilt University and University of Zambia|