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Trial record 4 of 406 for:    Open Studies | "Septicemia"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Vanderbilt University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Ben Andrews, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01663701
First received: August 8, 2012
Last updated: August 12, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Sepsis
Severe Sepsis
Tuberculosis
Other: Simplified severe sepsis protocol
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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: 212
Study Start Date: August 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care
Patients are managed according to admitting doctors' orders. Blood cultures are drawn in all patients. Antibiotics are specified by the admitting doctors.
Other: Usual care
Patients are managed according to admitting doctors' orders
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. Antibiotics are specified by the admitting doctors.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663701

Contacts
Contact: Benjamin Andrews, MD lauandrews@yahoo.com
Contact: Holly Cassell holly.cassell@vanderbilt.edu

Locations
Zambia
University Teaching Hospital Not yet recruiting
Lusaka, Zambia
Contact: Benjamin Andrews, MD       lauandrews@yahoo.com   
Contact: Levy Muchemwa, MBChB       levymuchemwa@yahoo.com   
Principal Investigator: Benjamin Andrews, MD         
Sub-Investigator: Shabir Lakhi, MBChBMMedMPH         
Sub-Investigator: Levy Muchemwa, MBChB         
Sponsors and Collaborators
Vanderbilt University
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: NCT01663701     History of Changes
Other Study ID Numbers: SSSP-2, R24TW007988
Study First Received: August 8, 2012
Last Updated: August 12, 2012
Health Authority: Zambia: Research Ethics Committee
United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Sepsis
Severe sepsis
Tuberculosis
Bundle
Zambia

Additional relevant MeSH terms:
Sepsis
Toxemia
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Infection
Inflammation
Mycobacterium Infections
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 25, 2014