Management of Sepsis in Resource Limited Settings Using a Delphi Method.

Sepsis Clinical Trial

Official title:

Expert Consensus Statements for the Management of Sepsis in Resource Limited Settings Using a Delphi Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05909384
• Other study ID #: APSADelphi_V1.2
• Status: Completed
• Start date: May 16, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The investigators aim to use a Delphi process to generate expert consensus practice statements in the context of diagnosis and management of sepsis in LMICs, including identification of aspects of sepsis diagnosis and management in LMICs not covered by existing guidelines. The questions will undergo several iterative rounds and will be in multiple-choice or Likert scale format. A study steering group will review the results of each round via video conference and design the questionnaire for the next survey. Summary results of each round will be presented to experts, along with the survey questionnaire for the next round. The survey process will be repeated with the modified questionnaire. The Delphi rounds will continue until the desired consensus and stability are achieved.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 30, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Recognized experts meeting pre-defined criteria (below) from a wide geographical distribution with approximately 70% from LMICs.

1. Clinical expertise in adult sepsis management, AND

2. Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities

Exclusion Criteria:

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Vietnam	Oxford University Clinical Research Unit	Ho Chi Minh City

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam	Asia Pacific Sepsis Alliance

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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