Simplified Severe Sepsis Protocol in Zambia

NCT ID: NCT01449916

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-11-30

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.

Detailed Description

In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. However, in sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Furthermore, although tuberculosis is a common cause of severe sepsis in the region, accurate and timely diagnosis of tuberculosis-associated severe sepsis remains elusive.

The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis, (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 (4) To assess the performance of the Xpert TB/RIF rapid PCR system for diagnosing tuberculosis in HIV positive patients with severe sepsis.

Conditions

Sepsis; Severe Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Simplified Severe Sepsis Protocol

Intervention Type: 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

Usual care

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

Group Type: ACTIVE_COMPARATOR

Simplified Severe Sepsis Protocol

Intervention Type: 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

Interventions

Simplified Severe Sepsis Protocol

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 or older
• Suspected infection
• 2 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
• 1 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
• Respiratory rate > 40/min
• Jaundice

Exclusion Criteria

• GI bleed
• Need for urgent surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin L Andrews, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University and University of Zambia

Locations

University Teaching Hospital

Lusaka, , Zambia

Countries

Zambia

Other Identifiers

R24TW007988

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SSSP

Identifier Type: -

Identifier Source: org_study_id