Sleep and Cytokines During Acute Diverticulitis

NCT01840852 | Completed DMC

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

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.

Conditions

Acute Diverticulitis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

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)