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Simplified Severe Sepsis Protocol in Zambia (SSSP)

This study is currently recruiting participants.
Verified June 2012 by Vanderbilt University
Sponsor:
Collaborators:
National Institutes of Health (NIH)
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Ben Andrews, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01449916
First received: October 5, 2011
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Sepsis
Severe Sepsis
 Other: Simplified Severe Sepsis Protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sepsis
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • In-hospital all cause mortality [ Time Frame: During hospitalization, expected average 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 28-day all-cause mortality [ Time Frame: 28-day ] [ Designated as safety issue: No ]
  • In-hospital all cause mortality adjusted for illness severity [ Time Frame: During hospitalization, expected average 14 days ] [ Designated as safety issue: No ]
    Adjusted for SAPS3 score

  • 28-day all cause mortality adjusted for baseline illness severity [ Time Frame: 28-day ] [ Designated as safety issue: No ]
    Adjusted for SAPS3 score

  • Cumulative adverse events [ Time Frame: During hospitalization, expected average 14 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The proportion of patients whose antibiotic regimen was changed due to information obtained from blood culture results.


Estimated Enrollment: 348
Study Start Date: February 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Other: Simplified Severe Sepsis Protocol
Early fluid protocol, early blood cultures and antibiotics; blood cultures and titrated dopamine in selected patients; monitoring based on vital signs and physical examination
Active Comparator: Usual care
Patients are managed according to admitting doctors' orders
 Other: Simplified Severe Sepsis Protocol
Early fluid protocol, early blood cultures and antibiotics; blood cultures and titrated dopamine in selected patients; monitoring based on vital signs and physical examination

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449916

Contacts
Contact: Benjamin L Andrews, MD lauandrews@yahoo.com

Locations
Zambia
University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Benjamin L Andrews, MD         lauandrews@yahoo.com    
Contact: Max Katubulushi         mkatubulushi@yahoo.co.uk    
Principal Investigator: Benjamin L Andrews, MD            
Sub-Investigator: Shabir Lakhi, MBChBMMedMPH            
Sub-Investigator: Levy Muchemwa, MBChB            
Sponsors and Collaborators
Vanderbilt University
National Institutes of Health (NIH)
John E. Fogarty International Center (FIC)
Investigators
Principal Investigator: Benjamin L Andrews, MD Vanderbilt University and University of Zambia
  More Information

No publications provided

Responsible Party: Ben Andrews, Global Health Research Fellow, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01449916     History of Changes
Other Study ID Numbers: SSSP, R24TW007988
Study First Received: October 5, 2011
Last Updated: June 6, 2012
Health Authority: Zambia: Research Ethics Committee
United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Sepsis
Severe Sepsis
Protocol
Zambia

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013