Circadian rhythms in children with chronic kidney disease stage 3_V1.0

• Research type

  Research Study

• Full title

  Renal circadian rhythms in children with chronic kidney disease stage 3 (CKD), diuresis, urinary excretion and blood pressure

• IRAS ID

  263116

• Contact name

  Rukshana Shroff

• Contact email

  Rukshana.Shroff@gosh.nhs.uk

• Sponsor organisation

  Great Ormond Street Hospital for Children NHS Foundation Trust

• Duration of Study in the UK

  0 years, 7 months, days

• Research summary

  In this observational, single centre study, we will evaluate the circadian rhythms of urinary output, i.e. urinary volume, sodium, potassium and osmolality in children with chronic kidney disease stage 3. The markers of urinary output will be linked to the results of a 24-hour blood pressure monitoring.
  Circadian rhythms are physical, mental, and behavioural changes that follow a daily cycle. Circadian rhythms can influence sleep-wake cycles, hormone release, eating habits and digestion, body temperature, and other important bodily functions. Biological clocks that run fast or slow can result in disrupted or abnormal circadian rhythms. Irregular rhythms have been linked to various chronic health conditions, such as sleep disorders and obesity.
  Chronic kidney disease stage 3 means, regarding the international guidelines, that there is kidney damage for ≥ 3 months, leading to a lower amount of blood that is filtered by the kidneys. Normally, this filtration rate is around 100-120 mL/min/1,73m2. In chronic kidney stage 3 the filtration rate drops to values between 60mL/min/1,73m2 and 30 ml/min/1,73m2, and chronic means that is lasts for ≥ 3 months.
  Objectives: The primary objective of the study is to evaluate the circadian rhythms of diuresis and urinary excretion of electrolytes.
  The secondary objective is to determine if there is a link between altered circadian rhythms of diuresis and/or urinary excretion of electrolytes and blood pressure during sleep.
  Population: 20 children (7 ≤ 14 years) with CKD stage 3
  Study duration: 7 months, including enrollment and data-analysis
  Subject participation: 1 month (approximately 2 weeks of data collection at home)
  duration
  Estimated time to complete enrolment: 31st of December 2019

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  19/NE/0193

• Date of REC Opinion

  8 Jun 2019

• REC opinion

  Favourable Opinion