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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01449916
Other study ID # SSSP
Secondary ID R24TW007988
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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