NCT01937676

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,250

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

August 30, 2013

Last Update Submit

September 3, 2016

Conditions

Multiple Organ Failure

Outcome Measures

Primary Outcomes (1)

  • Development of multiple organ failure

    Measured as SOFA score.

    30 days or complete ICU stay

Secondary Outcomes (2)

  • Cardiac function

    30 days or complete ICU stay

  • All cause mortality

    30 days after admission to emergency department

Study Arms (1)

Adults admitted to ER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients admitted to emergency department during study period.

You may qualify if:

  • Age ≥18 years
  • Admitted to emergency department, Karlstad Central Hospital, Sweden

You may not qualify if:

  • Not in need of venous blood sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karlstad Central Hospital

Karlstad, Sweden

Location

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mathias Karlsson, MD, PhD

    Karolinska

    PRINCIPAL INVESTIGATOR

  • Jan Wernerman, MD, Prof

    Karolinska

    STUDY DIRECTOR

  • Lars Wiklund, MD, Prof

    Uppsala University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 9, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2014

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

SE(1)