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

Sepsis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sepsis

Severe Sepsis

Tuberculosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Simplified severe sepsis protocolThis 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 carePatients are managed according to admitting doctors' orders

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Usual carePatients are managed according to admitting doctors' orders. Blood cultures are drawn in all patients. Antibiotics are specified by the admitting doctors.

Simplified Severe Sepsis ProtocolThis 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.

Study Status

Unknown status

Start Date: August 2012

Completed Date: September 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: In-hospital all cause mortality

Secondary Outcome: 28-day all-cause mortality

Study sponsors, principal investigator, and references

Principal Investigator: Benjamin L Andrews, MD

Lead Sponsor: Vanderbilt University

Collaborator: National Institutes of Health (NIH)

More information:https://clinicaltrials.gov/show/NCT01663701

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