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NCT Number: NCT01663701

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simplified severe sepsis protocol

Other

This protocol consists of an early aggressive fluid strategy, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings.

Usual Care

Other

Patients are managed according to admitting doctors' orders

Primary outcomes

  1. In-hospital all cause mortality

    Time frame: During hospitalization, expected average 14 days

Secondary outcomes

  1. 28-day all-cause mortality

    Time frame: 28-day

  2. In-hospital all cause mortality adjusted for illness severity

    Time frame: During hospitalization, expected average 14 days

    Adjusted for SAPS3 score

  3. 28-day all cause mortality adjusted for baseline illness severity

    Time frame: 28-day

    Adjusted for SAPS3 score

  4. Cumulative adverse events

    Time frame: During hospitalization, expected average 14 days

    A composite outcome consisting of dopamine extravasation, dopamine-associated tissue ischemia or necrosis, iatrogenic pulmonary oedema, and transfusion-related adverse events.

  5. Treatment cost per patient

    Time frame: During hospitalization, expected average 14 days

    A budget impact analysis will determine the cost of treatment per patient using a mix of direct measurements and micro-cost observation.

  6. Antibiotic changed due to culture results

    Time frame: During hospitalization, expected average 14 days

    The proportion of patients whose antibiotic regimen was changed due to information obtained from blood culture results.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • National Institutes of Health (NIH)

Registry information

Official study 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

Acronym: SSSP-2

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 13, 2012
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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