Simplified Severe Sepsis Protocol in Zambia

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT01449916
• Date of registration: 05/10/2011
• Prospective Registration: Yes
• Primary sponsor: Vanderbilt University
• Public title: Simplified Severe Sepsis Protocol in Zambia SSSP
• Scientific title: Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)
• Date of first enrolment: February 2012
• Target sample size: 112
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01449916
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Zambia

Contacts

• Name: Benjamin L Andrews, MD
• Affiliation: Vanderbilt University and University of Zambia

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sepsis

Severe Sepsis

Intervention(s)

Other: Simplified Severe Sepsis Protocol

Primary Outcome(s)

In-hospital all cause mortality [Time Frame: During hospitalization, expected average 14 days]

Secondary Outcome(s)

Treatment cost per patient [Time Frame: During hospitalization, expected average 14 days]

Cumulative adverse events [Time Frame: During hospitalization, expected average 14 days]

In-hospital all cause mortality adjusted for illness severity [Time Frame: During hospitalization, expected average 14 days]

Antibiotic changed due to culture results [Time Frame: During hospitalization, expected average 14 days]

28-day all cause mortality adjusted for baseline illness severity [Time Frame: 28-day]

28-day all-cause mortality [Time Frame: 28-day]

Secondary ID(s)

SSSP

R24TW007988

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fogarty International Center of the National Institute of Health

National Institutes of Health (NIH)