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

NCT03610074 | Completed

• 1 other identifier: 2017-03
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypernatremia; Dehydration

Keywords

thirst; mouth; critical care; water deprivation

Outcome Measures

Primary Outcomes (1)

• 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).

  at 5 minutes from mint ice cubes application

Secondary Outcomes (7)

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

  at 5 minutes from mint ice cubes application

• Time of appearance of the observed effect on thirst intensity

  over 24 hours from mint ice cubes application

• Duration of the observed effect on thirst intensity

  over 24 hours from mint ice cubes application

• Change of natremia at 5 minutes from mint ice cubes application

  at 5 minutes from mint ice cubes application

• Change of natremia at 24 hours from mint ice cubes application

  at 24 hours from mint ice cubes application

Study Arms (1)

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.

Other: Mint Ice Cube; Procedure: Blood test; Other: Patient's questioning

Interventions

Mint Ice Cube OTHER

Application in patient's mouth of 3 mint ice cubes

Mint ice cubes

Blood test PROCEDURE

Additional blood test 5 min after mint ice cubes application

Mint ice cubes

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

Mint ice cubes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication for ice cubes application in mouth
• Known mint allergy
• Incapability to understand study outcome and to answer basic questions
• Pregnancy
• Dying person

Sponsors & Collaborators

• Centre Hospitalier Arras: lead

Study Sites (2)

Centre Hospitalier d'Arras

Arras, France

Location

Centre Hospitalier de Lens

Lens, France

Location

MeSH Terms

Conditions

Hypernatremia; Dehydration

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Malcolm LEMYZE, MD

  Centre Hospitalier Arras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adult patient displaying an hypernatremia upper than 150mmol/L or an hypernatremia upper than 145mmol/L associated with a water deficiency upper than 3L

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: August 1, 2018
• Study Start: April 23, 2018
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)