Heart Rate Variability in the Course of Acute Uncomplicated Diverticulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Heart-rate variability changes during the acute uncomplicated diverticulitis compared to the baseline levels at 30th night where the condition has been cured
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Heart-rate variability changes during the acute uncomplicated diverticulitis compared to the baseline levels at 30th night where the condition has been cured
时间窗: 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.
次要结局
- changes in plasma cytokine levels during the acute uncomplicated diverticulitis from the baseline levels at 30th day (remission)(1st, 2nd and 30th days following the admission)
- change in Sleep data during the acute diverticulitis from baseline Sleep data at remission (30th day)(1st, 2nd and 30th days following the admission)
研究者
Ismail Gögenür
Senior resident and D.Sc.
Herlev Hospital