SepsisNCT00781040
Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients
An observational study of Sepsis, run by Kuopio University Hospital at 2 sites in Finland.
Trial summary
The aim of this study is to find out whether inflammation markers including cardiac markers have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Severe sepsis vs. non-severe sepsis
- How many people
- 273 participants
- Where
- 2 sitesFinland
- Study dates
- Dec 2006to 1 Jan 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neutropenic patients in haematology ward having neutropenic fever with or without severe sepsis
Who may be able to join
- diagnosis: acute myeloid leukaemia
- age under 70 years
- neutropenic fever
Who cannot join
- age above 70 years
- no neutropenic fever
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Kuopio University Hospital
Kuopio, 70211
Kuopio University Hospital
Kuopio
About this study
The aim of this study is to find out whether inflammation markers including cardiac markers have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological patients.
Read the detailed description
Adult AML and ASCT patients with neutropenic fever. Observation of possible progress to severe sepsis or septic shock. Blood sample collection on days 0-3 (from the beginning of neutropenic fever).
- Conditions
- Sepsis
- Being tested
- Severe sepsis vs. non-severe sepsis
- Keywords
- Severe sepsis in neutropenic haematological patients
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe sepsis vs. non-severe sepsisOther
Also called Severe sepsis vs. non-severe sepsis adult AML patients, Severe sepsis vs. non-severe sepsis adult ASCT patients
To compare these two groups
| Study group | Role | What they receive |
|---|---|---|
| Neutropenic patients | Adult AML and ASCT patients with neutropenic fever. Receives: Other: Severe sepsis vs. non-severe sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study evaluates epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of inflammatory markers.
This study evaluated epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of specific inflammatory markers.
Measured: Within neutropenic period after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startDec 2006
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sari Hamalainen, Kuopio University Hospital
- Investigators
- Esa Jantunen, M.D, PhD, Study director, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781040
- Sponsor's protocol ID
- KUH5101409
- Status last verified
- Feb 2019
- First submitted
- 27 Oct 2008
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vanska M, Koivula I, Hamalainen S, Pulkki K, Nousiainen T, Jantunen E, Juutilainen A. High pentraxin 3 level predicts septic shock and bacteremia at the onset of febrile neutropenia after intensive chemotherapy of hematologic patients. Haematologica. 2011 Sep;96(9):1385-9. doi: 10.3324/haematol.2011.044925.
PubMed 21880642
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutropenic Fever, Inflammatory Markers and Sepsis in Haematological Patients
- ClinicalTrials.gov ID
- NCT00781040
- Acronym / sponsor ID
- KUH5101409
- Conditions
- Sepsis
- Keywords
- Severe sepsis in neutropenic haematological patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 28 Oct 2008 (estimated)
- 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.
The aim of this study is to find out whether inflammation markers including cardiac markers have predictive value in evaluation of pathogenesis of sepsis in neutropenic haematological patients.
Detailed description
Adult AML and ASCT patients with neutropenic fever. Observation of possible progress to severe sepsis or septic shock. Blood sample collection on days 0-3 (from the beginning of neutropenic fever).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neutropenic patients | – | Other: Severe sepsis vs. non-severe sepsisAdult AML and ASCT patients with neutropenic fever. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neutropenic patients in haematology ward having neutropenic fever with or without severe sepsis
Key inclusion criteria (3 listed)
- diagnosis: acute myeloid leukaemia
- age under 70 years
- neutropenic fever
Key exclusion criteria (2 listed)
- age above 70 years
- no neutropenic fever
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 |
|---|---|---|
| Severe sepsis vs. non-severe sepsisAlso: Severe sepsis vs. non-severe sepsis adult AML patients, Severe sepsis vs. non-severe sepsis adult ASCT patientsTo compare these two groups | Other | Neutropenic patients |
Primary outcome
This study evaluates epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of inflammatory markers.
Time frame: Within neutropenic period after treatment
This study evaluated epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of specific inflammatory markers.
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 1 Mar 2019.
- Derived from this study: PubMed 21880642Vanska M, Koivula I, Hamalainen S, Pulkki K, Nousiainen T, Jantunen E, Juutilainen A. High pentraxin 3 level predicts septic shock and bacteremia at the onset of febrile neutropenia after intensive chemotherapy of hematologic patients. Haematologica. 2011 Sep;96(9):1385-9. doi: 10.3324/haematol.2011.044925.
- Individual participant dataSharing planned: No
Related trials for Sepsis
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Esa Jantunen, M.D, PhD study director
Kuopio University Hospital
2 sites 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 Kuopio University Hospital at 2 sites in Finland.
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 2 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 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
This study evaluates epidemiology, microbiology and outcome of neutropenic fever and severe sepsis in haematological patients with special reference to the kinetics of inflammatory markers. (time frame: Within neutropenic period after treatment). 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 NCT00781040, 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 1 Mar 2019.