Simplified Severe Sepsis Protocol in Zambia

Not Applicable

Terminated

• Conditions: Severe Sepsis; Sepsis
• Interventions: Other: Simplified Severe Sepsis Protocol

• Registration Number: NCT01449916
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-10
• Study Start: 2012-02
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Simplified Severe Sepsis Protocol	Early blood cultures and antibiotics. Monitoring by study nurses as in experimental arm. Other interventions are according to admitting (non-study) doctors' orders.
Simplified Severe Sepsis Protocol	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.

Primary Outcome Measures

Name	Time	Method
In-hospital all cause mortality	During hospitalization, expected average 14 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia