Heart Rate Variability During Acute Diverticulitis | NCT01840917

Studies
Heart Rate Variability During Acute Diverticulitis

NCT01840917

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Feb 25, 2014Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Acute Diverticulitis

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Apr 13, 2013

First Submission Date that Met QC Criteria

Apr 23, 2013

First Posted Date

Apr 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2014

Last Update Posted Date

Feb 25, 2014Estimated

Name	Class
Lundbeck Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

13Actual

Label	Type	Description	Intervention Names
acute uncomplicated diverticulitis		CT-verified acute uncomplicated diverticulitis managed by antibiotics

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ismail Gögenur, M.D.	University of Copenhagen, Herlev Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department D, Herlev Hospital		Herlev	Copenhagen	2730	Denmark