Simplified Severe Sepsis Protocol-2 (SSSP-2) in Zambia

Sepsis Clinical Trial

— SSSP-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663701
• Other study ID #: SSSP-2
• Secondary ID: R24TW007988
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• infection suspected by the treating physician
• 2 or more of the following SIRS criteria:
• - Heart rate >90/min
• Respiratory rate >20/min
• - Temperature = 38° C or < 36° C
• White blood count > 12,000 or < 4,000/µL
• 1 of the following:
• Systolic blood pressure (SBP) = 90 mm Hg
• Mean arterial blood pressure (MAP) = 65 mm Hg

Exclusion Criteria:

• Gastrointestinal bleed in the absence of fever
• Need for immediate surgery
• Respiratory rate greater than 40/min with oxygen saturation less than 90%
• Suspected congestive heart failure exacerbation
• End-stage renal disease
• Raised jugular venous pressure (JVP) at baseline
• Currently incarcerated

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia
• Tuberculosis

Intervention

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.
• Usual care
Patients are managed according to admitting doctors' orders

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital all cause mortality		During hospitalization, expected average 14 days
Secondary	28-day all-cause mortality		28-day
Secondary	In-hospital all cause mortality adjusted for illness severity	Adjusted for SAPS3 score	During hospitalization, expected average 14 days
Secondary	28-day all cause mortality adjusted for baseline illness severity	Adjusted for SAPS3 score	28-day
Secondary	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
Secondary	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
Secondary	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