Clinical trial NCT01840852: Sleep and Cytokines During Acute Diverticulitis
Official title: the Effects of Inflammatory Cytokines on Sleep During Acute Diverticulitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Diverticulitis
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2013-04-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

Brief summary: The purpose of this study is to investigate sleep disturbances during Acute uncomplicated diverticulitis by polysomnography. The investigators hypothesis is the inflammation causes REM(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.

Detailed description: An increasing number of experimental studies have showed that inflammation can induce disturbances in sleep architecture, mediated by cytokines. Sleep is important both in health and disease processes and can affect recovery, morbidity and mortality.

Studies have been done on sleep disturbances after major and minor GI-surgery but never in relation to none surgical inflammatory diseases, namely acute diverticulitis.

This study will investigate sleep architecture by Polysomnography and inflammation by levels of pro inflammatory cytokines in plasma.

Following methods will be applied

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

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

Primary outcomes:
measure: change in Sleep architecture during acute uncomplicated diverticulitis from baseline at the remission (30th day)
timeFrame: 1st, 2nd and 30th nights following the admission
measure: change in cytokine levels in plasma during the acute uncomplicated diverticulitis from baseline levels at remission
timeFrame: 1st, 2nd and 30th nights following the admission
measure: change in CRP level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission
timeFrame: 1st, 2nd and 30th nights following the admission
measure: change in leucocyte level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission
timeFrame: 1st, 2nd and 30th nights following the admission
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department D, Herlev Hospital
state: Copenhagen
Study officials:
affiliation: University of Copenhagen, Herlev Hospital
name: Ismail Gögenur, M.D.
role: PRINCIPAL_INVESTIGATOR
References: