Simplified Severe Sepsis Protocol in Zambia (SSSP)

Vanderbilt University

Status: Terminated

Conditions: Severe Sepsis; Sepsis

Treatments: Other: Simplified Severe Sepsis Protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01449916

R24TW007988 (U.S. NIH Grant/Contract)

SSSP

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 in Zambia. 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.

Full description

In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. However, in sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Furthermore, although tuberculosis is a common cause of severe sepsis in the region, accurate and timely diagnosis of tuberculosis-associated severe sepsis remains elusive.

The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis, (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 (4) To assess the performance of the Xpert TB/RIF rapid PCR system for diagnosing tuberculosis in HIV positive patients with severe sepsis.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older

• Suspected infection

• 2 or more of 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 or more of the following signs of end-organ dysfunction

  • Systolic blood pressure < 90 mm Hg
  • Mean arterial blood pressure (MAP) < 65 mm Hg
  • Confusion/altered mentation
  • Urine output < 0.5 mL/kg/hr
  • Creatinine increase > 0.5 mg/dL
  • Creatinine > 0.5 mg/dL above upper limit of normal
  • Platelet < 100x109/L
  • Respiratory rate > 40/min
  • Jaundice

Exclusion criteria

• GI bleed
• Need for urgent surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

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.

Treatment:

Other: Simplified Severe Sepsis Protocol

Usual care

Active Comparator group

Description:

Early blood cultures and antibiotics. Monitoring by study nurses as in experimental arm. Other interventions are according to admitting (non-study) doctors' orders.

Treatment:

Other: Simplified Severe Sepsis Protocol