Heart Rate Variability During Acute Diverticulitis

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Ismail Gögenür, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01840917
First received: April 13, 2013
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition
Acute Diverticulitis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Heart Rate Variability in the Course of Acute Uncomplicated Diverticulitis

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Heart-rate variability measured by Holter monitor and a following analysis of frequency and time domain parameters.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    the blood sample is taken at night before sleep time. the cytokines are measured with ELISA-kit

  • 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 ] [ Designated as safety issue: No ]
    Sleep data is measured by Polysomnography and sleep is categorized into sleep stages (awake, stage 1, 2, REM-sleep and SWS-sleep)


Biospecimen Retention:   Samples Without DNA

plasma


Enrollment: 13
Study Start Date: April 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
acute uncomplicated diverticulitis
CT-verified acute uncomplicated diverticulitis managed by antibiotics

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

16 x Acute uncomplicated diverticulitis (Hansen and stock stage 1) patients aged 18-75 years managed by antibiotic treatment at Herlev Hospital

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840917

Locations
Denmark
Department D, Herlev Hospital
Herlev, Copenhagen, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Lundbeck Foundation
Investigators
Principal Investigator: Ismail Gögenur, M.D. University of Copenhagen, Herlev Hospital
  More Information

No publications provided

Responsible Party: Ismail Gögenür, Senior resident and D.Sc., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01840917     History of Changes
Other Study ID Numbers: CHU-4
Study First Received: April 13, 2013
Last Updated: February 24, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 20, 2014