Heart Rate Variability During Acute Diverticulitis

Acute Diverticulitis Clinical Trial

Official title:

Heart Rate Variability in the Course of Acute Uncomplicated Diverticulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840917
• Other study ID #: CHU-4
• Status: Completed
• Phase: N/A
• First received: April 13, 2013
• Last updated: February 24, 2014
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis

Locations

Country	Name	City	State
Denmark	Department D, Herlev Hospital	Herlev	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No