Heart Rate Variability During Acute Diverticulitis

NCT01840917 | Completed DMC

• 1 other identifier: CHU-4
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diverticulitis

Outcome Measures

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

  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 Outcomes (2)

• 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 admission

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

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

Study Arms (1)

acute uncomplicated diverticulitis

CT-verified acute uncomplicated diverticulitis managed by antibiotics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev Hospital: lead
• Lundbeck Foundation: collaborator

Study Sites (1)

Department D, Herlev Hospital

Herlev, Copenhagen, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

Study Officials

• Ismail Gögenur, M.D.

  University of Copenhagen, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior resident and D.Sc.

Study Record Dates

• First Submitted: April 13, 2013
• First Posted: April 26, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

DK (1)