AzTrials
AzTrials

Hip FractureHRVHipNCT03426501

Association Between HRV and Postoperative Mortality in Hip Fracture Patients

An observational study of Hip Fracture, run by Vestre Viken Hospital Trust.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hip Fracture
How many people
165 participants
Where
No sites listed yet
Study dates
15 Jan 2008to 31 Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Pastients with hip fractures

Who may be able to join

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

Who cannot join

  • 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

About this study

Official title: Association Between Heart Rate Variability and Perioperative and Long-term Mortality in Patients With Hip Fracture - an Observational Study

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.

Read the detailed description

Patients with hip fractures admitted to Kongsberg hospital and o Oslo University Hospital between 2008 and 2013 were invited to participate in the study. Hemodynamically unstable patients, patients where it was impossible to obtain a 5 or 10-minute ECG signal (e.g. due to delirium), patients having undergone surgery the last month, cancer patients, patients with hip fractures due to high energy trauma, and patients considered moribund at admission, were excluded. A 5-10-minute ECG signal was recorded within 24 hours after arrival preoperatively and digitalized.

Heart rate was obtained by a Biocom 3000 ECG recorder (Kongsberg) and a Biocom 4000 ECG recorder (Oslo). The Biocom 3000 and 4000 ECG interface units use dry silver/ silver chloride ECG electrodes attached to the index fingers of the right and the left hand, respectively. Participants were asked to relax for 5 minutes. Afterwards, they were connected to the ECG, and a continuous ECG signal was obtained over 10 minutes (Kongsberg) or 5 minutes (Oslo). Linear parameters (time domain: SDNN, rMSSD; frequency domain: HF, LF, VLF, LF/HF) were calculated by a Heart Rhythm Scanner - Version 2.0 - (Biocom Technologies - U.S.A). Both signal measurement and processing was done according to international recommendations.

The investigators analysed HRV both in time domain and frequency domain. Time domain analysis measures the intervals between successive normal cardiac cycles. SDNN (the standard deviation of the NN intervals) reflects all the cyclic components responsible for variability in the period of recording and correlates strongly with total power (TP) of the frequency domain. rMSSD (root mean square successive difference) is calculated by drawing the square root of the mean value of the squared NN intervals. In healthy persons, the rMSSD value is 27 ± 12 ms. It estimates high-frequency variations in heart rate and correlates accordingly mostly with HF in the frequency domain. Changes in this parameter might show a decreased parasympathetic tone and discordance in sympathovagal activity.

Frequency domain (power spectral density) analysis describes the periodic oscillations of the heart rate signal, decomposed at different frequencies and amplitudes, and provides information on the amount of their relative intensity (termed variance of power) in the sinus rhythm of the heart. It is calculated with help of power spectral density by the fast Fourier transformation. Frequently reported indices are TP (total power), VLF (very low frequency power, < 0.003 -0.04 Hz), LF (low-frequency power, 0.04-0.15 Hz), HF (high-frequency power, 0.15-0.4 Hz), and the LF/HF ratio. It is recommended not to calculate VLF values from recordings lasting five minutes or less because VLF has a cycle period of 20 seconds to 5 minutes The measurement period should be at least twice as long as the cycle duration. The investigators therefore used only time series of 10 minutes (from the Kongsberg group) for calculation of VLF.

All ECGs were manually edited according to the Task force of the European Society of cardiology. If containing more than 30% pathological QRS-complexes, the patients' data were excluded.

The sample size was estimated according to reference values reported earlier. The calculation was based on mortality as the most important outcome. Assuming very conservatively a 6-months mortality between 3 and 8%, 150 patients would be sufficient to test the hypothesis that there is a significant association between linear HRV-measurements and mortality. However, the investigators also addressed other incidents than mortality, most of which occur more frequently.

In the statistical analysis, the investigators used the independent samples T test for univariate analysis and ANOVA for multivariate analysis. For nominal data, the Chi-Square test or Fisher's exact test were used, as appropriate. In case of very different group sizes (in the case of postoperative pneumonia) the investigators used the nonparametric Mann-Whitney-U-test. Statistical analyses were run by the Statistical Package for Social Sciences (SPSS), release 18.0.3 (September 2010). Values are given in mean +/- SEM if not otherwise stated.

Every person in Norway is identified by a unique number in the Central Personal Register. Deceased patients were identified by the Norwegian central address register which provides exact data for the time of death. In addition, patients, close relatives of patients and in some cases their general physicians or nursing home physicians were interviewed six months postoperatively in the Kongsberg group regarding pneumonia, cardiac events and stroke. In the Oslo group patients, close relatives of patients and in some cases their general physicians or nursing home physicians were interviewed regarding pneumonia, cardiac events and stroke within the first six months postoperatively. In both groups the results of the interviews were cross-validated by the hospital journals and - if relevant - nursery home journals regarding new hospital admissions within six months after the operation date.

The study protocol was reviewed and approved of the Regional Committee for Medical and Health Research Ethics of Southern Norway (11.1.2008, S-07307b) and the Data Protection Officer of Oslo University Hospital.

Conditions
Hip Fracture
Keywords
heart rate variability, prognosis
Medical subject headings
Hip Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Surviving patients six months after hip operation

    Mortality according to the Central Population Register

    Measured: 6 months etter inclusion

Secondary outcomes (3)
  1. Pneumonia

    Pneumonia was diagnosed according to the presence of a new infiltrate in the chest radiograph and the presence of acute respiratory symptoms

    Measured: 6 months etter inclusion

  2. Stroke

    Stroke diagnosed according to the National Guideline of Stroke diagnosis and Treatment

    Measured: 6 months etter inclusion

  3. Myocardial infarction

    Myocardial infarction was diagnosed by increase of Troponin, ST-segment changes in ECG, Q Waves or/and regional wall motion abnormality in imaging studies.

    Measured: 6 months etter inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start15 Jan 2008
  3. Primary completion31 Dec 2014
  4. Study completion31 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426501
Sponsor's protocol ID
HRVhofte
Acronym
HRVHip
Status last verified
Feb 2018
First submitted
25 Jan 2018
Last updated
8 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No share intended

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Fracture, run by Vestre Viken Hospital Trust.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Surviving patients six months after hip operation (time frame: 6 months etter inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in