Multiple Organ FailureNCT01937676
LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting
An observational study of Multiple Organ Failure, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the emergency department can be used to predict the development of organ failure measured as SOFA score. K3 consists of lactate dehydrogenase, albumin and magnesium combined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Organ Failure
- How many people
- 1,250 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted to emergency department during study period.
Who may be able to join
- Age ≥18 years
- Admitted to emergency department, Karlstad Central Hospital, Sweden
Who cannot join
- Not in need of venous blood sample
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the emergency department can be used to predict the development of organ failure measured as SOFA score. K3 consists of lactate dehydrogenase, albumin and magnesium combined.
- Conditions
- Multiple Organ Failure
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults admitted to ER | All adult patients admitted to emergency department during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of multiple organ failure
Measured as SOFA score.
Measured: 30 days or complete ICU stay
Secondary outcomes (2)
Cardiac function
Is it possible to predict cardiac function with the novel biomarker K3, which consists of lactate dehydrogenase, albumin, and magnesium combined?
Measured: 30 days or complete ICU stay
All cause mortality
Measured: 30 days after admission to emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ FailureStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fredrik Helliksson, Karolinska Institutet
- Investigators
- Mathias Karlsson, MD, PhD, Principal investigator, KarolinskaJan Wernerman, MD, Prof, Study director, KarolinskaLars Wiklund, MD, Prof, Study director, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937676
- Sponsor's protocol ID
- K3-akuten
- Status last verified
- Sep 2016
- First submitted
- 30 Aug 2013
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting
- ClinicalTrials.gov ID
- NCT01937676
- Acronym / sponsor ID
- K3-akuten
- Conditions
- Multiple Organ Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- First posted
- 9 Sep 2013 (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 purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the emergency department can be used to predict the development of organ failure measured as SOFA score. K3 consists of lactate dehydrogenase, albumin and magnesium combined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults admitted to ER | – | –All adult patients admitted to emergency department during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to emergency department during study period.
Key inclusion criteria (2 listed)
- Age ≥18 years
- Admitted to emergency department, Karlstad Central Hospital, Sweden
Key exclusion criteria (1 listed)
- Not in need of venous blood sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of multiple organ failure
Time frame: 30 days or complete ICU stay
Measured as SOFA score.
2 secondary outcomes
Cardiac function
Time frame: 30 days or complete ICU stay
All cause mortality
Time frame: 30 days after admission to emergency department
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 7 Sep 2016.
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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.
Mathias Karlsson, MD, PhD principal investigator
Karolinska
Jan Wernerman, MD, Prof study director
Karolinska
Lars Wiklund, MD, Prof study director
Uppsala University
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 Multiple Organ Failure, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 1 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 7 Sep 2016. 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 Sweden. 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?
Development of multiple organ failure (time frame: 30 days or complete ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2016.