Relieve the Patient's Thirst, Refresh the Mouth First (ICU-MIC)

Dehydration Clinical Trial

— ICU-MIC  

Official title:

Relieve the Patient's Thirst, Refresh the Mouth First

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610074
• Other study ID #: 2017-03
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: March 8, 2019

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Arras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Hypernatremia

Intervention

Other:
• Mint Ice Cube
Application in patient's mouth of 3 mint ice cubes

Procedure:
• Blood test
Additional blood test 5 min after mint ice cubes application

Other:
• Patient's questioning
Patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application

Locations

Country	Name	City	State
France	Centre Hospitalier d'Arras	Arras
France	Centre Hospitalier de Lens	Lens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Arras

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of thirst intensity at 5 minutes from mint ice cubes application	The primary endpoint is a change of thirst intensity of at least 1.5 points on the thirst intensity scale at 5 minutes from mint ice cubes application. Thirst intensity scale is a numeric scale ranging from 0 to 10 points. 0 corresponds to no thirst (the best outcome). 10 corresponds to a thirst of the strongest possible intensity (the worst outcome).	at 5 minutes from mint ice cubes application
Secondary	Change of thirst-associated discomfort at 5 minutes from mint ice cubes application	This secondary endpoint is a change of thirst-associated discomfort on the discomfort scale at 5 minutes from mint ice cubes application. The discomfort scale is a numeric scale ranging from on a 0 to 5 points. 0 corresponds to "very comfortable" (the best outcome). 5 corresponds to "very uncomfortable" (the worst outcome).	at 5 minutes from mint ice cubes application
Secondary	Time of appearance of the observed effect on thirst intensity	This secondary endpoint is the delay (in minutes) between mint ice cubes application and the observed effect on thirst intensity.	over 24 hours from mint ice cubes application
Secondary	Duration of the observed effect on thirst intensity	This secondary endpoint measures how much time (in minutes) mint ice cubes application keeps working on thirst intensity.	over 24 hours from mint ice cubes application
Secondary	Change of natremia at 5 minutes from mint ice cubes application	Natremia (in mmol/L)	at 5 minutes from mint ice cubes application
Secondary	Change of natremia at 24 hours from mint ice cubes application	Natremia (in mmol/L)	at 24 hours from mint ice cubes application
Secondary	Change of plasma osmolarity at 5 minutes from mint ice cubes application	Plasma osmolarity (in mmol/L)	at 5 minutes from mint ice cubes application
Secondary	Change of plasma osmolarity at 24 hours from mint ice cubes application	Plasma osmolarity (in mmol/L)	at 24 hours from mint ice cubes application