NCT05909384

Brief Summary

Rapid evolution of sepsis syndromes means that timely diagnosis and treatment are critical in improving outcomes but this may be difficult to achieve in many low- and middle- income countries (LMICs) and there is a lack of high quality clinical evidence to guide diagnosis and management in LMIC settings. The wide variability in health systems in LMICs means that additional areas of guidance may be required where staff or facilities are lacking. In the absence of clinical data, to address some of these issues, the investigators aim to use Delphi methodology to obtain experts consensus statements on some specific aspects of sepsis management in LMICs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

May 16, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

May 19, 2023

Last Update Submit

January 17, 2024

Conditions

Keywords

SepsisSeptic shockLow- and middle- income countriesLMICDelphiResource-limited setting

Outcome Measures

Primary Outcomes (1)

  • Questionnaire statements which have reached pre-defined consensus

    Descriptive analysis of questionnaire statements which have reached pre-defined consensus. Consensus will be defined as \>70% participants in favour of agree/disagree statements (Likert scale 1-3 means disagree or 5-7 means agree), or \>80% in favour of single option in a single stem question with multiple responses (yes/no answers).

    2 weeks

Study Arms (1)

Expert group

1. Clinical expertise in adult sepsis management, AND 2. Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities

Other: Survey

Interventions

SurveyOTHER

Multiple rounds of surveys collecting information on sepsis diagnosis and management in resource-limited settings.

Expert group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recognized experts meeting pre-defined criteria from a wide geographical distribution with approximately 70% from LMICs

You may qualify if:

  • Recognized experts meeting pre-defined criteria (below) from a wide geographical distribution with approximately 70% from LMICs.
  • Clinical expertise in adult sepsis management, AND
  • Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Clinical Research Unit

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Brett Abbenbroek, BSc,MPH,PhD

    The George Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2023

First Posted

June 18, 2023

Study Start

May 16, 2023

Primary Completion

August 21, 2023

Study Completion

September 30, 2023

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations