SepsisNCT05909384
Management of Sepsis in Resource Limited Settings Using a Delphi Method.
An observational study of Sepsis, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- What is being tested?
- Survey
- How many people
- 36 participants
- Where
- 1 siteVietnam
- Study dates
- 16 May 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be recognized experts meeting pre-defined criteria from a wide geographical distribution with approximately 70% from LMICs
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expert Consensus Statements for the Management of Sepsis in Resource Limited Settings Using a Delphi Method
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.
Read the detailed 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.
- Conditions
- Sepsis
- Being tested
- Survey
- Keywords
- Sepsis, Septic shock, Low- and middle- income countries, LMIC, Delphi, Resource-limited setting
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Multiple rounds of surveys collecting information on sepsis diagnosis and management in resource-limited settings.
| Study group | Role | What they receive |
|---|---|---|
| Expert group | 1. Clinical expertise in adult sepsis management, AND
2. Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start16 May 2023
- Primary completion21 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Asia Pacific Sepsis Alliance
- Responsible party
- Sponsor
- Investigators
- Brett Abbenbroek, BSc,MPH,PhD, Study director, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909384
- Sponsor's protocol ID
- APSADelphi_V1.2
- Status last verified
- Jan 2024
- First submitted
- 19 May 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thwaites L, Nasa P, Abbenbroek B, Dat VQ, Finfer S, Kwizera A, Ling L, Lobo SM, Sinto R, Aditianingsih D, Antonelli M, Arabi YM, Argent A, Azevedo L, Bennett E, Chakrabarti A, De Asis K, De Waele J, Divatia JV, Estenssoro E, Evans L, Faiz A, Hammond NE, Hashmi M, Herridge MS, Jacob ST, Jatsho J, Javeri Y, Khalid K, Chen LK, Levy M, Lundeg G, Machado FR, Mehta Y, Mer M, Son DN, Ospina-Tascon GA, Ostermann M, Permpikul C, Prescott HC, Reinhart K, Rodriguez Vega G, S-Kabara H, Shrestha GS, Waweru-Siika W, Tan TL, Todi S, Tripathy S, Venkatesh B, Vincent JL, Myatra SN. Management of adult sepsis in resource-limited settings: global expert consensus statements using a Delphi method. Intensive Care Med. 2025 Jan;51(1):21-38. doi: 10.1007/s00134-024-07735-7. Epub 2024 Dec 23.
PubMed 39714613
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expert Consensus Statements for the Management of Sepsis in Resource Limited Settings Using a Delphi Method
- ClinicalTrials.gov ID
- NCT05909384
- Acronym / sponsor ID
- APSADelphi_V1.2
- Conditions
- Sepsis
- Keywords
- Sepsis, Septic shock, Low- and middle- income countries, LMIC, Delphi, Resource-limited setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- Asia Pacific Sepsis Alliance
- Study start
- 16 May 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expert group | – | Other: Survey1. Clinical expertise in adult sepsis management, AND 2. Demonstrated involvement with sepsis related research, educations, policy/protocols, professional activities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recognized experts meeting pre-defined criteria from a wide geographical distribution with approximately 70% from LMICs
Key inclusion criteria (3 listed)
- Recognized experts meeting pre-defined criteria (below) from a wide geographical distribution with approximately 70% from LMICs.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyMultiple rounds of surveys collecting information on sepsis diagnosis and management in resource-limited settings. | Other | Expert group |
Primary outcome
Questionnaire statements which have reached pre-defined consensus
Time frame: 2 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 39714613Thwaites L, Nasa P, Abbenbroek B, Dat VQ, Finfer S, Kwizera A, Ling L, Lobo SM, Sinto R, Aditianingsih D, Antonelli M, Arabi YM, Argent A, Azevedo L, Bennett E, Chakrabarti A, De Asis K, De Waele J, Divatia JV, Estenssoro E, Evans L, Faiz A, Hammond NE, Hashmi M, Herridge MS, Jacob ST, Jatsho J, Javeri Y, Khalid K, Chen LK, Levy M, Lundeg G, Machado FR, Mehta Y, Mer M, Son DN, Ospina-Tascon GA, Ostermann M, Permpikul C, Prescott HC, Reinhart K, Rodriguez Vega G, S-Kabara H, Shrestha GS, Waweru-Siika W, Tan TL, Todi S, Tripathy S, Venkatesh B, Vincent JL, Myatra SN. Management of adult sepsis in resource-limited settings: global expert consensus statements using a Delphi method. Intensive Care Med. 2025 Jan;51(1):21-38. doi: 10.1007/s00134-024-07735-7. Epub 2024 Dec 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Abbenbroek, BSc,MPH,PhD study director
The George Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire statements which have reached pre-defined consensus (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.