HypernatremiaICU-MICNCT03610074
Relieve the Patient's Thirst, Refresh the Mouth First (ICU-MIC)
A study testing Mint Ice Cube, Blood test and Patient's questioning in people with Hypernatremia and Dehydration, run by Centre Hospitalier Arras at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypernatremia, Dehydration
- What is being tested?
- Mint Ice Cube, Blood test and Patient's questioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Apr 2018to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication for ice cubes application in mouth
- Known mint allergy
- Incapability to understand study outcome and to answer basic questions
- Pregnancy
- Dying person
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Relieve the Patient's Thirst, Refresh the Mouth First
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.
- Conditions
- Hypernatremia, Dehydration
- Being tested
- Mint Ice Cube, Blood test, Patient's questioning
- Keywords
- thirst, mouth, critical care, water deprivation
- Medical subject headings
- Hypernatremia, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mint Ice CubeOther
Application in patient's mouth of 3 mint ice cubes
Blood testProcedure or surgery
Additional blood test 5 min after mint ice cubes application
Patient's questioningOther
Patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application
| Study group | Role | What they receive |
|---|---|---|
| Mint ice cubes | Experimental | 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. Receives: Other: Mint Ice Cube; Procedure: Blood test; Other: Patient's questioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 5 minutes from mint ice cubes application
Secondary outcomes (7)
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).
Measured: at 5 minutes from mint ice cubes application
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.
Measured: over 24 hours from mint ice cubes application
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.
Measured: over 24 hours from mint ice cubes application
Change of natremia at 5 minutes from mint ice cubes application
Natremia (in mmol/L)
Measured: at 5 minutes from mint ice cubes application
Change of natremia at 24 hours from mint ice cubes application
Natremia (in mmol/L)
Measured: at 24 hours from mint ice cubes application
Change of plasma osmolarity at 5 minutes from mint ice cubes application
Plasma osmolarity (in mmol/L)
Measured: at 5 minutes from mint ice cubes application
Change of plasma osmolarity at 24 hours from mint ice cubes application
Plasma osmolarity (in mmol/L)
Measured: at 24 hours from mint ice cubes application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start23 Apr 2018
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypernatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Arras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm LEMYZE, MD, Principal investigator, Centre Hospitalier Arras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610074
- Sponsor's protocol ID
- 2017-03
- Acronym
- ICU-MIC
- Status last verified
- Mar 2019
- First submitted
- 21 Jun 2018
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relieve the Patient's Thirst, Refresh the Mouth First
- ClinicalTrials.gov ID
- NCT03610074
- Acronym / sponsor ID
- ICU-MIC / 2017-03
- Conditions
- Hypernatremia, Dehydration
- Keywords
- thirst, mouth, critical care, water deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier ArrasUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Mint ice cubes | Experimental | Other: Mint Ice Cube, Procedure: Blood test, Other: Patient's questioningPhysician 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Contraindication for ice cubes application in mouth
- Known mint allergy
- Incapability to understand study outcome and to answer basic questions
- Pregnancy
- Dying person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mint Ice CubeApplication in patient's mouth of 3 mint ice cubes | Other | Mint ice cubes |
| Blood testAdditional blood test 5 min after mint ice cubes application | Procedure or surgery | Mint ice cubes |
| Patient's questioningPatient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application | Other | Mint ice cubes |
Primary outcome
Change of thirst intensity at 5 minutes from mint ice cubes application
Time frame: 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).
7 secondary outcomes
Change of thirst-associated discomfort at 5 minutes from mint ice cubes application
Time frame: at 5 minutes from mint ice cubes application
Time of appearance of the observed effect on thirst intensity
Time frame: over 24 hours from mint ice cubes application
Duration of the observed effect on thirst intensity
Time frame: over 24 hours from mint ice cubes application
Change of natremia at 5 minutes from mint ice cubes application
Time frame: at 5 minutes from mint ice cubes application
Change of natremia at 24 hours from mint ice cubes application
Time frame: at 24 hours from mint ice cubes application
Change of plasma osmolarity at 5 minutes from mint ice cubes application
Time frame: at 5 minutes from mint ice cubes application
Change of plasma osmolarity at 24 hours from mint ice cubes application
Time frame: at 24 hours from mint ice cubes application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm LEMYZE, MD principal investigator
Centre Hospitalier Arras
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mint Ice Cube, Blood test and Patient's questioning in people with Hypernatremia and Dehydration, run by Centre Hospitalier Arras at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of thirst intensity at 5 minutes from mint ice cubes application (time frame: at 5 minutes from mint ice cubes application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.