Acute DiverticulitisNCT01840917
Heart Rate Variability During Acute Diverticulitis
An observational study of Acute Diverticulitis, run by Herlev Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Diverticulitis
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Acute Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute uncomplicated diverticulitis | CT-verified acute uncomplicated diverticulitis managed by antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
the blood sample is taken at night before sleep time. the cytokines are measured with ELISA-kit
Measured: 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)
Measured: 1st, 2nd and 30th days following the admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Ismail Gögenür, Herlev Hospital
- Investigators
- Ismail Gögenur, M.D., Principal investigator, University of Copenhagen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840917
- Sponsor's protocol ID
- CHU-4
- Status last verified
- Feb 2014
- First submitted
- 13 Apr 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in the Course of Acute Uncomplicated Diverticulitis
- ClinicalTrials.gov ID
- NCT01840917
- Acronym / sponsor ID
- CHU-4
- Conditions
- Acute Diverticulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Apr 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute uncomplicated diverticulitis | – | –CT-verified acute uncomplicated diverticulitis managed by antibiotics |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart-rate variability changes during the acute uncomplicated diverticulitis compared to the baseline levels at 30th night where the condition has been cured
Time frame: 1st, 2nd and 30th night following the admission
Heart-rate variability measured by Holter monitor and a following analysis of frequency and time domain parameters.
2 secondary outcomes
changes in plasma cytokine levels during the acute uncomplicated diverticulitis from the baseline levels at 30th day (remission)
Time frame: 1st, 2nd and 30th days following the admission
change in Sleep data during the acute diverticulitis from baseline Sleep data at remission (30th day)
Time frame: 1st, 2nd and 30th days following the admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Gögenur, M.D. principal investigator
University of Copenhagen, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Diverticulitis, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart-rate variability changes during the acute uncomplicated diverticulitis compared to the baseline levels at 30th night where the condition has been cured (time frame: 1st, 2nd and 30th night following the admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.