Clinical trial NCT03610074: Relieve the Patient's Thirst, Refresh the Mouth First (ICU-MIC)
Official title: Relieve the Patient's Thirst, Refresh the Mouth First
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypernatremia
Dehydration
Keywords: thirst
mouth
critical care
water deprivation
Lead sponsor: Centre Hospitalier Arras
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adult patient displaying an hypernatremia upper than 150mmol/L or an hypernatremia upper than 145mmol/L associated with a water deficiency upper than 3L
Primary purpose: BASIC_SCIENCE

Brief summary: Thirst is considered as one of the most distressing symptoms experienced by patients hospitalized in the Intensive Care Unit (ICU). Whereas pain is a permanent concern for all caregivers, thirst is often ignored and its complications are poorly known. Mechanisms involved in thirst regulation are numerous and complex. To date, care of thirst is still non optimal. Critically ill patients are usually rehydrated intravenously or using a naso-gastric tube, thus shunting the mouth as a therapeutic target to relieve the patient's thirst.

Water, cold and mint applied in mouth were studied separately and were shown to decrease thirst significantly on animal models and healthy humans.

Therefore, the hypothesis of this study is that application of small mint ice cubes in mouth of very dehydrated ICU patients should allow decreasing quickly and significantly thirst for these patients, before the correction of their biological parameters, like natremia and osmolarity.


Eligibility criteria: Inclusion Criteria:

* Hypernatremia upper than 150mmol/L or hypernatremia upper than 145mmol/L associated with water deficiency upper than 3L
* Estimated hospitalization duration in ICU upper than 24h

Exclusion Criteria:

* Contraindication for ice cubes application in mouth
* Known mint allergy
* Incapability to understand study outcome and to answer basic questions
* Pregnancy
* Dying person

Primary outcomes:
measure: Change of thirst intensity at 5 minutes from mint ice cubes application
timeFrame: at 5 minutes from mint ice cubes application
Secondary outcomes:
measure: Change of thirst-associated discomfort at 5 minutes from mint ice cubes application
timeFrame: at 5 minutes from mint ice cubes application
measure: Time of appearance of the observed effect on thirst intensity
timeFrame: over 24 hours from mint ice cubes application
measure: Duration of the observed effect on thirst intensity
timeFrame: over 24 hours from mint ice cubes application
measure: Change of natremia at 5 minutes from mint ice cubes application
timeFrame: at 5 minutes from mint ice cubes application
measure: Change of natremia at 24 hours from mint ice cubes application
timeFrame: at 24 hours from mint ice cubes application
measure: Change of plasma osmolarity at 5 minutes from mint ice cubes application
timeFrame: at 5 minutes from mint ice cubes application
measure: Change of plasma osmolarity at 24 hours from mint ice cubes application
timeFrame: at 24 hours from mint ice cubes application
Other outcomes:
Locations:
city: Arras
country: France
facility: Centre Hospitalier d'Arras
city: Lens
country: France
facility: Centre Hospitalier de Lens
Study officials:
affiliation: Centre Hospitalier Arras
name: Malcolm LEMYZE, MD
role: PRINCIPAL_INVESTIGATOR
References: