NCT02960256

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 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

November 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

November 2, 2016

Last Update Submit

March 13, 2018

Conditions

SepsisPneumoniaCardiomyopathy, Secondary

Outcome Measures

Primary Outcomes (1)

  • Prolongation of the QT

    QT will be measured by ECG

    5 days

Study Arms (1)

Patients admitted to an internal medicine department due to an

Device: ekocardiogram test

Interventions

ekocardiogram testDEVICE

ekocardiogram test

Patients admitted to an internal medicine department due to an

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

SepsisPneumoniaCardiomyopathies

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesHeart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 9, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)