Simplified Severe Sepsis Protocol in Zambia

NCT01449916 | Terminated DMC

• 2 other identifiers: SSSPR24TW007988
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Severe Sepsis

Keywords

Sepsis; Severe Sepsis; Protocol; Zambia

Outcome Measures

Primary Outcomes (1)

• In-hospital all cause mortality

  During hospitalization, expected average 14 days

Secondary Outcomes (6)

• 28-day all-cause mortality

  28-day

• In-hospital all cause mortality adjusted for illness severity

  During hospitalization, expected average 14 days

• 28-day all cause mortality adjusted for baseline illness severity

  28-day

• Cumulative adverse events

  During hospitalization, expected average 14 days

• Treatment cost per patient

  During hospitalization, expected average 14 days

Study Arms (2)

Simplified Severe Sepsis Protocol

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

Early blood cultures and antibiotics. Monitoring by study nurses as in experimental arm. Other interventions are according to admitting (non-study) doctors' orders.

Other: Simplified Severe Sepsis Protocol

Interventions

Simplified Severe Sepsis Protocol OTHER

Early fluid protocol, early blood cultures and antibiotics; blood cultures and titrated dopamine in selected patients; monitoring based on vital signs and physical examination

Simplified Severe Sepsis Protocol; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Suspected infection
• 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
• 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

You may not qualify if:

• GI bleed
• Need for urgent surgery

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institutes of Health (NIH): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin L Andrews, MD

  Vanderbilt University and University of Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 10, 2011
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)