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Completed

NCT Number: NCT03610074

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

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.

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Key information

Conditions

Hypernatremia Dehydration Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Arras, Arras, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mint Ice Cube

Other

Application in patient's mouth of 3 mint ice cubes

Blood test

Procedure

Additional blood test 5 min after mint ice cubes application

Patient's questioning

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change of thirst-associated discomfort at 5 minutes from mint ice cubes application

    Time frame: 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).

  2. Time of appearance of the observed effect on thirst intensity

    Time frame: over 24 hours from mint ice cubes application

    This secondary endpoint is the delay (in minutes) between mint ice cubes application and the observed effect on thirst intensity.

  3. Duration of the observed effect on thirst intensity

    Time frame: over 24 hours from mint ice cubes application

    This secondary endpoint measures how much time (in minutes) mint ice cubes application keeps working on thirst intensity.

  4. Change of natremia at 5 minutes from mint ice cubes application

    Time frame: at 5 minutes from mint ice cubes application

    Natremia (in mmol/L)

  5. Change of natremia at 24 hours from mint ice cubes application

    Time frame: at 24 hours from mint ice cubes application

    Natremia (in mmol/L)

  6. Change of plasma osmolarity at 5 minutes from mint ice cubes application

    Time frame: at 5 minutes from mint ice cubes application

    Plasma osmolarity (in mmol/L)

  7. Change of plasma osmolarity at 24 hours from mint ice cubes application

    Time frame: at 24 hours from mint ice cubes application

    Plasma osmolarity (in mmol/L)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Arras

Other

Registry information

Official study title

Relieve the Patient's Thirst, Refresh the Mouth First

Acronym: ICU-MIC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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