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

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

      • Karlstad, Sweden
        • Karlstad Central Hospital

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
Adults admitted to ER
All adult patients admitted to emergency department during the study period.

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
Measured as SOFA score.
30 days or complete ICU stay

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function
Time Frame: 30 days or complete ICU stay
Is it possible to predict cardiac function with the novel biomarker K3, which consists of lactate dehydrogenase, albumin, and magnesium combined?
30 days or complete ICU stay
All cause mortality
Time Frame: 30 days after admission to emergency department
30 days after admission to emergency department

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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