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

Vanderbilt University

Status: Completed

Conditions: Tuberculosis; Severe Sepsis; Sepsis

Treatments: Other: Usual care; Other: Simplified severe sepsis protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01663701

R24TW007988 (U.S. NIH Grant/Contract)

SSSP-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 212 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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212 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Patients are managed according to admitting doctors' orders. Blood cultures are drawn in all patients. Antibiotics are specified by the admitting doctors.

Treatment:

Other: Usual care

Simplified Severe Sepsis Protocol

Experimental group

Description:

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.

Treatment:

Other: Simplified severe sepsis protocol