Heart Rate Variability During Acute Diverticulitis

Heart Rate Variability in the Course of Acute Uncomplicated 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.

Study Overview

• Status: Completed
• Conditions: Acute Diverticulitis

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

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Herlev, Copenhagen, Denmark, 2730
      • Department D, Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
acute uncomplicated diverticulitis; CT-verified acute uncomplicated diverticulitis managed by antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart-rate variability changes during the acute uncomplicated diverticulitis compared to the baseline levels at 30th night where the condition has been cured	Heart-rate variability measured by Holter monitor and a following analysis of frequency and time domain parameters.	1st, 2nd and 30th night following the admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in plasma cytokine levels during the acute uncomplicated diverticulitis from the baseline levels at 30th day (remission)	the blood sample is taken at night before sleep time. the cytokines are measured with ELISA-kit	1st, 2nd and 30th days following the admission
change in Sleep data during the acute diverticulitis from baseline Sleep data at remission (30th day)	Sleep data is measured by Polysomnography and sleep is categorized into sleep stages (awake, stage 1, 2, REM-sleep and SWS-sleep)	1st, 2nd and 30th days following the admission

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Collaborators: Lundbeck Foundation
• Investigators: Principal Investigator: Ismail Gögenur, M.D., University of Copenhagen, Herlev Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: April 13, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Estimate): February 25, 2014
• Last Update Submitted That Met QC Criteria: February 24, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis
• Other Study ID Numbers: CHU-4