Relieve the Patient's Thirst, Refresh the Mouth First (ICU-MIC) (ICU-MIC)
Primary Purpose
Hypernatremia, Dehydration
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mint Ice Cube
Blood test
Patient's questioning
Sponsored by
About this trial
This is an interventional basic science trial for Hypernatremia focused on measuring thirst, mouth, critical care, water deprivation
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
Sites / Locations
- Centre Hospitalier d'Arras
- Centre Hospitalier de Lens
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mint ice cubes
Arm Description
Physician applies 3 mint ice cubes in mouth of highly dehydrated patient. Patient undergoes an additional blood test at 5 min from mint ice cubes application. Physician performs patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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.
Change of natremia at 5 minutes from mint ice cubes application
Natremia (in mmol/L)
Change of natremia at 24 hours from mint ice cubes application
Natremia (in mmol/L)
Change of plasma osmolarity at 5 minutes from mint ice cubes application
Plasma osmolarity (in mmol/L)
Change of plasma osmolarity at 24 hours from mint ice cubes application
Plasma osmolarity (in mmol/L)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03610074
Brief Title
Relieve the Patient's Thirst, Refresh the Mouth First (ICU-MIC)
Acronym
ICU-MIC
Official Title
Relieve the Patient's Thirst, Refresh the Mouth First
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
March 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Arras
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypernatremia, Dehydration
Keywords
thirst, mouth, critical care, water deprivation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mint ice cubes
Arm Type
Experimental
Arm Description
Physician applies 3 mint ice cubes in mouth of highly dehydrated patient. Patient undergoes an additional blood test at 5 min from mint ice cubes application.
Physician performs patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application.
Intervention Type
Other
Intervention Name(s)
Mint Ice Cube
Intervention Description
Application in patient's mouth of 3 mint ice cubes
Intervention Type
Procedure
Intervention Name(s)
Blood test
Intervention Description
Additional blood test 5 min after mint ice cubes application
Intervention Type
Other
Intervention Name(s)
Patient's questioning
Intervention Description
Patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application
Primary Outcome Measure Information:
Title
Change of thirst intensity at 5 minutes from mint ice cubes application
Description
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).
Time Frame
at 5 minutes from mint ice cubes application
Secondary Outcome Measure Information:
Title
Change of thirst-associated discomfort at 5 minutes from mint ice cubes application
Description
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).
Time Frame
at 5 minutes from mint ice cubes application
Title
Time of appearance of the observed effect on thirst intensity
Description
This secondary endpoint is the delay (in minutes) between mint ice cubes application and the observed effect on thirst intensity.
Time Frame
over 24 hours from mint ice cubes application
Title
Duration of the observed effect on thirst intensity
Description
This secondary endpoint measures how much time (in minutes) mint ice cubes application keeps working on thirst intensity.
Time Frame
over 24 hours from mint ice cubes application
Title
Change of natremia at 5 minutes from mint ice cubes application
Description
Natremia (in mmol/L)
Time Frame
at 5 minutes from mint ice cubes application
Title
Change of natremia at 24 hours from mint ice cubes application
Description
Natremia (in mmol/L)
Time Frame
at 24 hours from mint ice cubes application
Title
Change of plasma osmolarity at 5 minutes from mint ice cubes application
Description
Plasma osmolarity (in mmol/L)
Time Frame
at 5 minutes from mint ice cubes application
Title
Change of plasma osmolarity at 24 hours from mint ice cubes application
Description
Plasma osmolarity (in mmol/L)
Time Frame
at 24 hours from mint ice cubes application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm LEMYZE, MD
Organizational Affiliation
Centre Hospitalier Arras
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier d'Arras
City
Arras
Country
France
Facility Name
Centre Hospitalier de Lens
City
Lens
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Relieve the Patient's Thirst, Refresh the Mouth First (ICU-MIC)
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