Clinical trial NCT01449916: Simplified Severe Sepsis Protocol in Zambia
Official title: Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sepsis
Severe Sepsis
Keywords: Sepsis
Severe Sepsis
Protocol
Zambia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Fogarty International Center of the National Institute of Health
First posted: 2011-10-10
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: In-hospital all cause mortality
timeFrame: During hospitalization, expected average 14 days
Secondary outcomes:
measure: 28-day all-cause mortality
timeFrame: 28-day
measure: In-hospital all cause mortality adjusted for illness severity
timeFrame: During hospitalization, expected average 14 days
measure: 28-day all cause mortality adjusted for baseline illness severity
timeFrame: 28-day
measure: Cumulative adverse events
timeFrame: During hospitalization, expected average 14 days
measure: Treatment cost per patient
timeFrame: During hospitalization, expected average 14 days
measure: Antibiotic changed due to culture results
timeFrame: During hospitalization, expected average 14 days
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: Vanderbilt University and University of Zambia
name: Benjamin L Andrews, MD
role: PRINCIPAL_INVESTIGATOR
References: