NCT03426501

Brief Summary

165 patients admitted to two hospitals were included and short-time HRV measurements were obtained. Mortality data were gathered from the Norwegian central address register. Patients, close relatives of patients and in some cases their general physicians or nursery home physicians were interviewed six months postoperatively regarding the incidence of pneumonia, cardiac events or stroke.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 15, 2008

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

7 years

First QC Date

January 25, 2018

Last Update Submit

February 7, 2018

Conditions

Hip Fracture

Keywords

heart rate variabilityprognosis

Outcome Measures

Primary Outcomes (1)

  • Number of Surviving patients six months after hip operation

    Mortality according to the Central Population Register

    6 months etter inclusion

Secondary Outcomes (3)

  • Pneumonia

    6 months etter inclusion

  • Stroke

    6 months etter inclusion

  • Myocardial infarction

    6 months etter inclusion

Eligibility Criteria

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

Pastients with hip fractures

You may qualify if:

  • Hip fracture with indication of operative treatment.
  • Preoperative ECG
  • Preoperative CKMB and Troponin I

You may not qualify if:

  • Cardiocirculatoric unstable patient Atrial fibrillation
  • Agitated patient were it is unpossible to obtain a 10 minute ECG
  • Other operation in the last month
  • Cancer patients in an advanced stadium
  • Preterminal or terminal patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

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

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 8, 2018

Study Start

January 15, 2008

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

February 8, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

No share intended