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Heart Rate Variability During Acute Diverticulitis

Heart Rate Variability in the Course of Acute Uncomplicated Diverticulitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01840917
Enrollment
13
Registered
2013-04-26
Start date
2013-04-30
Completion date
2013-11-30
Last updated
2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diverticulitis

Brief 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.

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

Interventions

None listed

Sponsors

Lundbeck Foundation
CollaboratorOTHER
Herlev Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Heart-rate variability changes during the acute uncomplicated diverticulitis compared to the baseline levels at 30th night where the condition has been cured1st, 2nd and 30th night following the admissionHeart-rate variability measured by Holter monitor and a following analysis of frequency and time domain parameters.

Secondary

MeasureTime frameDescription
changes in plasma cytokine levels during the acute uncomplicated diverticulitis from the baseline levels at 30th day (remission)1st, 2nd and 30th days following the admissionthe 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)1st, 2nd and 30th days following the admissionSleep data is measured by Polysomnography and sleep is categorized into sleep stages (awake, stage 1, 2, REM-sleep and SWS-sleep)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026