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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05909384
Other study ID # APSADelphi_V1.2
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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:

Study Design


Related Conditions & MeSH terms


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
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