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

NCT ID: NCT03610074

Last Updated: 2019-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-23

Study Completion Date

2019-03-08

Brief Summary

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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.

Detailed Description

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Conditions

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Hypernatremia Dehydration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Adult patient displaying an hypernatremia upper than 150mmol/L or an hypernatremia upper than 145mmol/L associated with a water deficiency upper than 3L
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mint ice cubes

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.

Group Type EXPERIMENTAL

Mint Ice Cube

Intervention Type OTHER

Application in patient's mouth of 3 mint ice cubes

Blood test

Intervention Type PROCEDURE

Additional blood test 5 min after mint ice cubes application

Patient's questioning

Intervention Type OTHER

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

Interventions

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Mint Ice Cube

Application in patient's mouth of 3 mint ice cubes

Intervention Type OTHER

Blood test

Additional blood test 5 min after mint ice cubes application

Intervention Type PROCEDURE

Patient'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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Arras

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malcolm LEMYZE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Arras

Locations

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Centre Hospitalier d'Arras

Arras, , France

Site Status

Centre Hospitalier de Lens

Lens, , France

Site Status

Countries

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France

Other Identifiers

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2017-03

Identifier Type: -

Identifier Source: org_study_id

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