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

Relieve the Patient's Thirst, Refresh the Mouth First

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03610074
Acronym
ICU-MIC
Enrollment
26
Registered
2018-08-01
Start date
2018-04-23
Completion date
2019-03-08
Last updated
2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Hypernatremia

Keywords

thirst, mouth, critical care, water deprivation

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.

Interventions

OTHERMint Ice Cube

Application in patient's mouth of 3 mint ice cubes

PROCEDUREBlood test

Additional blood test 5 min after mint ice cubes application

OTHERPatient'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

Sponsors

Centre Hospitalier Arras
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of thirst intensity at 5 minutes from mint ice cubes applicationat 5 minutes from mint ice cubes applicationThe 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).

Secondary

MeasureTime frameDescription
Time of appearance of the observed effect on thirst intensityover 24 hours from mint ice cubes applicationThis secondary endpoint is the delay (in minutes) between mint ice cubes application and the observed effect on thirst intensity.
Duration of the observed effect on thirst intensityover 24 hours from mint ice cubes applicationThis secondary endpoint measures how much time (in minutes) mint ice cubes application keeps working on thirst intensity.
Change of natremia at 5 minutes from mint ice cubes applicationat 5 minutes from mint ice cubes applicationNatremia (in mmol/L)
Change of thirst-associated discomfort at 5 minutes from mint ice cubes applicationat 5 minutes from mint ice cubes applicationThis 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).
Change of plasma osmolarity at 5 minutes from mint ice cubes applicationat 5 minutes from mint ice cubes applicationPlasma osmolarity (in mmol/L)
Change of plasma osmolarity at 24 hours from mint ice cubes applicationat 24 hours from mint ice cubes applicationPlasma osmolarity (in mmol/L)
Change of natremia at 24 hours from mint ice cubes applicationat 24 hours from mint ice cubes applicationNatremia (in mmol/L)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026