An interventional study of Mint Ice Cube and Blood test in Hypernatremia and Dehydration, sponsored by Centre Hospitalier Arras. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-01.
Sponsored by Centre Hospitalier Arras · Not applicable, Interventional, and Basic science
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.
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's enrollment of 26 is below the median of 64 across 32 interventional studies indexed under Hypernatremia.
Browse Hypernatremia studies →Centre Hospitalier Arras is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Mint Ice Cube · Procedure: Blood test · Other: Patient's questioning
Application in patient's mouth of 3 mint ice cubes
Additional blood test 5 min after mint ice cubes application
Patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application
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).
Time frame: at 5 minutes from mint ice cubes application
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 frame: 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.
Time frame: 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.
Time frame: over 24 hours from mint ice cubes application
Change of natremia at 5 minutes from mint ice cubes application
Natremia (in mmol/L)
Time frame: at 5 minutes from mint ice cubes application
Change of natremia at 24 hours from mint ice cubes application
Natremia (in mmol/L)
Time frame: 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)
Time frame: 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)
Time frame: at 24 hours from mint ice cubes application
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Arras