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Completed

NCT Number: NCT01840917

Heart Rate Variability During Acute Diverticulitis

The purpose of this study is to investigate heart rate variability during Acute uncomplicated diverticulitis by ECG-monitor (Holter), the investigators hypothesis is the inflammation causes a decrease of High Frequency(HF)-power component of heart rate variability and this correlates with sleep quality and daytime fatigue.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department D, Herlev Hospital

Herlev, Copenhagen, 2730, Denmark

About this study

An increasing number of studies have shown that circadian variation in the excretion of hormones, the sleep-wake cycle, the core body temperature, the tone of the autonomic nervous system and the activity rhythm are important both in health and disease processes. The investigators are interested in investigating the heart rate variability (HRV) during an acute surgical non-inflammatory condition, and to exam whether there are correlations between: HRV and sleep stages, HRV and cytokine levels in blood and HRV and subjective fatigue.

Following methods will be applied

Device: Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England)

Other: Karolinska Sleepiness Scale

Other: Physical Fatigue Scale

Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)

Procedure: Plasma cytokines (IL-2, IL-6 and TNF(tumor necrosis factor)-alfa)

Procedure: Plasma CRP(C reactive protein) and leukocytes

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CT-verified diverticulitis patients managed by antibiotic treatment at Herlev Hospital
  • Pain and fever occurred less than 72 hours prior to the admission
  • ASA (American Society of Anesthesiologists) score I to III

Exclusion criteria

  • Surgical intervention needed
  • Complicated diverticulitis
  • Complications in relation to diverticulitis
  • Pain and fever occurred more than 72 hours prior to the admission
  • In anticoagulant treatment and heart rate control treatment
  • Known Autoimmune disease
  • Known medically treated sleep-disorder (insomnia, restless legs etc.) and sleep apnea
  • Shift-work or jetlag
  • Daily use of opioid, psychopharmaca, opioids or anxiolytics (including Hypnotics)
  • Known psychiatry conditions in treatment with psychopharmaca
  • Daily alcohol intake of more than 5 units or drug abuse
  • Missing written consent
  • Diabetes Mellitus
  • Predicted bad compliance
  • Pregnant or breast-feeding
  • Urine or fecal incontinence
  • Severe kidney disease
  • Current cancer

Treatment and study plan

Primary outcomes

  1. Heart-rate variability changes during the acute uncomplicated diverticulitis compared to the baseline levels at 30th night where the condition has been cured

    Time frame: 1st, 2nd and 30th night following the admission

    Heart-rate variability measured by Holter monitor and a following analysis of frequency and time domain parameters.

Secondary outcomes

  1. changes in plasma cytokine levels during the acute uncomplicated diverticulitis from the baseline levels at 30th day (remission)

    Time frame: 1st, 2nd and 30th days following the admission

    the blood sample is taken at night before sleep time. the cytokines are measured with ELISA-kit

  2. change in Sleep data during the acute diverticulitis from baseline Sleep data at remission (30th day)

    Time frame: 1st, 2nd and 30th days following the admission

    Sleep data is measured by Polysomnography and sleep is categorized into sleep stages (awake, stage 1, 2, REM-sleep and SWS-sleep)

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

Heart Rate Variability in the Course of Acute Uncomplicated Diverticulitis

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 26, 2013
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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