NCT01663701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P50-P75 for not_applicable sepsis

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

August 8, 2012

Last Update Submit

September 23, 2021

Conditions

SepsisSevere SepsisTuberculosis

Keywords

SepsisSevere sepsisTuberculosisBundleZambia

Outcome Measures

Primary Outcomes (1)

  • In-hospital all cause mortality

    During hospitalization, expected average 14 days

Secondary Outcomes (6)

  • 28-day all-cause mortality

    28-day

  • In-hospital all cause mortality adjusted for illness severity

    During hospitalization, expected average 14 days

  • 28-day all cause mortality adjusted for baseline illness severity

    28-day

  • Cumulative adverse events

    During hospitalization, expected average 14 days

  • Treatment cost per patient

    During hospitalization, expected average 14 days

  • +1 more secondary outcomes

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Other: Usual care

Simplified Severe Sepsis Protocol

EXPERIMENTAL

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.

Other: Simplified severe sepsis protocol

Interventions

Simplified severe sepsis protocolOTHER

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

Simplified Severe Sepsis Protocol
Usual careOTHER

Patients are managed according to admitting doctors' orders

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (1)

  • 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.

    PMID: 28973227DERIVED

MeSH Terms

Conditions

SepsisTuberculosis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Benjamin L Andrews, MD

    Vanderbilt University and University of Zambia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 13, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

January 1, 2014

Last Updated

September 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Requests for data sharing should be directed to PI. PI will then confer with Zambian co-PI to confirm that data sharing is allowable by Zambian law.

Locations

ZA(1)