Simplified Severe Sepsis Protocol in Zambia

Sepsis Clinical Trial

— SSSP  

Official title:

Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01449916
• Other study ID #: SSSP
• Secondary ID: R24TW007988
• Status: Terminated
• Phase: N/A
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: September 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Intervention

Other:
• 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

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital all cause mortality		During hospitalization, expected average 14 days
Secondary	28-day all-cause mortality		28-day
Secondary	In-hospital all cause mortality adjusted for illness severity	Adjusted for SAPS3 score	During hospitalization, expected average 14 days
Secondary	28-day all cause mortality adjusted for baseline illness severity	Adjusted for SAPS3 score	28-day
Secondary	Cumulative adverse events	A composite outcome consisting of dopamine extravasation, dopamine-associated tissue ischemia or necrosis, iatrogenic pulmonary oedema, and transfusion-related adverse events.	During hospitalization, expected average 14 days
Secondary	Treatment cost per patient	A budget impact analysis will determine the cost of treatment per patient using a mix of direct measurements and micro-cost observation.	During hospitalization, expected average 14 days
Secondary	Antibiotic changed due to culture results	The proportion of patients whose antibiotic regimen was changed due to information obtained from blood culture results.	During hospitalization, expected average 14 days