- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937676
LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting
September 3, 2016 updated by: Fredrik Helliksson, Karolinska Institutet
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Karlstad, Sweden
- Karlstad Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All adult patients admitted to emergency department during study period.
Description
Inclusion Criteria:
- Age ≥18 years
- Admitted to emergency department, Karlstad Central Hospital, Sweden
Exclusion Criteria:
- Not in need of venous blood sample
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Adults admitted to ER
All adult patients admitted to emergency department during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of multiple organ failure
Time Frame: 30 days or complete ICU stay
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Measured as SOFA score.
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30 days or complete ICU stay
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac function
Time Frame: 30 days or complete ICU stay
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Is it possible to predict cardiac function with the novel biomarker K3, which consists of lactate dehydrogenase, albumin, and magnesium combined?
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30 days or complete ICU stay
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All cause mortality
Time Frame: 30 days after admission to emergency department
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30 days after admission to emergency department
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mathias Karlsson, MD, PhD, Karolinska
- Study Director: Jan Wernerman, MD, Prof, Karolinska
- Study Director: Lars Wiklund, MD, Prof, Uppsala University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
August 30, 2013
First Submitted That Met QC Criteria
September 4, 2013
First Posted (Estimate)
September 9, 2013
Study Record Updates
Last Update Posted (Estimate)
September 7, 2016
Last Update Submitted That Met QC Criteria
September 3, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K3-akuten
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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