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

NCT01663701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2021-09-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

OTHER

Usual care

Patients are managed according to admitting doctors' orders

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Benjamin L Andrews, MD · Vanderbilt University and University of Zambia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-11-30
Completion
2014-01-31

Countries

  • Zambia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01663701 on ClinicalTrials.gov