Sleep and Cytokines During Acute Diverticulitis

Acute Diverticulitis Clinical Trial

Official title:

the Effects of Inflammatory Cytokines on Sleep During Acute Diverticulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840852
• Other study ID #: CHU-1
• Status: Completed
• Phase: N/A
• First received: April 13, 2013
• Last updated: February 24, 2014
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis

Locations

Country	Name	City	State
Denmark	Department D, Herlev Hospital	Herlev	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Sleep architecture during acute uncomplicated diverticulitis from baseline at the remission (30th day)	Sleep architecture measured by Polysomnography (awake, stadium I-IV, REM sleep, sleep latency, awakenings)	1st, 2nd and 30th nights following the admission	No
Primary	change in cytokine levels in plasma during the acute uncomplicated diverticulitis from baseline levels at remission	the Blood sample is taken prior to night sleep; Cytokines are measured by commercial ELISA-kits	1st, 2nd and 30th nights following the admission	No
Primary	change in CRP level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission	the Blood sample is taken prior to night sleep; CRP is measured by standardized conventional method	1st, 2nd and 30th nights following the admission	No
Primary	change in leucocyte level in plasma during the acute uncomplicated diverticulitis from baseline levels at remission	the Blood sample is taken prior to night sleep; Leucocyte is measured by standardized conventional method	1st, 2nd and 30th nights following the admission	No