LDH as a Biochemical Biomarker to Predict Organ Failure i... | NCT01937676

Studies
LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting

NCT01937676

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Sep 7, 2016Estimated

Enrollment

1,250Actual

Phase

Not provided

Conditions

Multiple Organ Failure

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Not provided

First Submitted Date

Aug 30, 2013

First Submission Date that Met QC Criteria

Sep 4, 2013

First Posted Date

Sep 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults admitted to ER		All adult patients admitted to emergency department during the study period.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of multiple organ failure	Measured as SOFA score.	30 days or complete ICU stay

Secondary Outcomes

Measure	Description	Time Frame
Cardiac function	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Not in need of venous blood sample

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adult patients admitted to emergency department during study period.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathias Karlsson, MD, PhD	Karolinska	Principal Investigator
Jan Wernerman, MD, Prof	Karolinska	Study Director
Lars Wiklund, MD, Prof	Uppsala University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karlstad Central Hospital		Karlstad			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D009102	Multiple Organ Failure

Ancestor Terms

ID	Term
D012769	Shock
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided