The Impact of Infectious Disease on QT Segment | NCT02960256

Studies
The Impact of Infectious Disease on QT Segment

NCT02960256

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Mar 14, 2018Actual

Enrollment

169Actual

Phase

Not provided

Conditions

Sepsis
Pneumonia
Cardiomyopathy, Secondary

Interventions

ekocardiogram test

Countries

Israel

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

Mar 2018

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

Dec 2016Actual

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Nov 2, 2016

First Submission Date that Met QC Criteria

Nov 8, 2016

First Posted Date

Nov 9, 2016Estimated

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

Mar 13, 2018

Last Update Posted Date

Mar 14, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lee Goldstein, Principal Investigator, HaEmek Medical Center, IsraelPrincipal Investigator

Lead Sponsor

HaEmek Medical Center, IsraelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Sepsis related to the development of cardiac complications. However, the investigators understanding regarding this condition remains incomplete. Possible explanations raised include coronary perfusion decrease, activation of the coagulation system and release of inflammatory mediators, including endotoxins, cytokines and others.

In this study the investigators wanted to examine the impact of any infectious disease, (not necessarily Pneumonia), on the QT interval in patients hospitalized for acute infectious disease.

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

169Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients admitted to an internal medicine department due to an			Device: ekocardiogram test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ekocardiogram test	Device	ekocardiogram test	Patients admitted to an internal medicine department due to an

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prolongation of the QT	QT will be measured by ECG	5 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Internal ward hospitalized patient, due to illness which its etiology is bacterial, fungal or viral

Exclusion Criteria:

Can not technically perform reliably ECG (amputated legs, lack of cooperation, etc.)
Subject with permanent pacemaker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

patients admitted to an internal medicine department due to an infectious disease.

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D011014	Pneumonia
D009202	Cardiomyopathies

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided