Simplified Severe Sepsis Protocol-2 (SSSP-2) in Zambia

NCT ID: NCT01663701

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-01-31

Brief Summary

This study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis with hypotension in Zambia. This is a follow-up study to the Simplified Severe Sepsis Protocol (SSSP) study. 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 and hypotension.

Detailed Description

In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. In sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Studies of fluid interventions in the region, however, have demonstrated conflicting results. Outcomes in septic patients may be further affected by delays in the diagnosis of tuberculosis-associated severe sepsis.

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

Conditions

Sepsis; Severe Sepsis; Tuberculosis

Study Design

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

Study Groups

Usual care

Patients are managed according to admitting doctors' orders. Blood cultures are drawn in all patients. Antibiotics are specified by the admitting doctors.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Patients are managed according to admitting doctors' orders

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. Antibiotics are specified by the admitting doctors.

Group Type: EXPERIMENTAL

Simplified severe sepsis protocol

Intervention Type: OTHER

This protocol consists of an early aggressive fluid strategy, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings.

Interventions

Simplified severe sepsis protocol

This protocol consists of an early aggressive fluid strategy, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings.

Intervention Type: OTHER

Usual care

Patients are managed according to admitting doctors' orders

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• infection suspected by the treating physician
• 2 or more of the following 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 of the following:
• Systolic blood pressure (SBP) ≤ 90 mm Hg
• Mean arterial blood pressure (MAP) ≤ 65 mm Hg

Exclusion Criteria

• Gastrointestinal bleed in the absence of fever
• Need for immediate surgery
• Respiratory rate greater than 40/min with oxygen saturation less than 90%
• Suspected congestive heart failure exacerbation
• End-stage renal disease
• Raised jugular venous pressure (JVP) at baseline
• Currently incarcerated

• 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

References

Andrews B, Semler MW, Muchemwa L, Kelly P, Lakhi S, Heimburger DC, Mabula C, Bwalya M, Bernard GR. Effect of an Early Resuscitation Protocol on In-hospital Mortality Among Adults With Sepsis and Hypotension: A Randomized Clinical Trial. JAMA. 2017 Oct 3;318(13):1233-1240. doi: 10.1001/jama.2017.10913.

Reference Type: DERIVED

PMID: 28973227 (View on PubMed)

Other Identifiers

R24TW007988

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SSSP-2

Identifier Type: -

Identifier Source: org_study_id