Thirst-guided Subject-controlled Rehydration in Healthy Volunteers

Dehydration Hypertonic Clinical Trial

Official title:

Thirst-guided Subject-controlled Rehydration in Healthy Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03932890
• Other study ID #: SFEC 2018-053A
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Water is largest single component to the human body and is requisite for numerous essential metabolic processes. Dehydration refers to deficient body water content and is prevalent in healthcare. It has been repeatedly shown that dehydration is associated with increased mortality and morbidity. Despite its prevalence and deleterious sequelae, there is substantial deficiency in the knowledge, assessment and management of this pathological state: there is no internationally-recognised definition, clinical signs can be subtle and unreliable, and there is no objective marker with everyday clinical utility. As a consequence, diagnosis of dehydration and prompt rehydration strategies are often poorly delivered in healthcare environments.

Thirst plays an integral part in body water homeostasis. Plasma osmolality will increase with uncompensated water loss and is considered the most reliable surrogate objective marker of dehydration. Increased osmolality is sensed by hypothalamic osmoreceptors stimulating thirst and pituitary secretion of antidiuretic hormone (ADH). Thirst has been shown to be sensitive to small changes in plasma osmolality and shows little intra-individual variation. In view of this, it is rational to propose tendering control of intravenous rehydration to patients, enabling them to use the finely-honed intrinsic thirst mechanism to guide their own fluid therapy. A recent pilot study demonstrated that healthy subjects, when allowed to regulate their own intravenous fluid therapy in response to thirst intensity, rehydrated themselves more efficiently than subjects receiving a guideline-based, clinician-delivered fluid regimen. What is unclear is the extent of the reliability of thirst in guiding intravenous fluid rehydration therapy.

The investigators propose a double-blinded, repeated measures study in which healthy volunteers are dehydrated using exercise-heat stress in a climatic chamber. Once dehydrated by 3-5% of their body weight, subjects will receive intravenous fluid rehydration which they can demand in response to their sensation of thirst. In one arm of the study they will receive low volume fluid bolus on demand, and in the other arm they will receive a higher volume fluid bolus. Thirst scores and surrogate markers of dehydration will be measured throughout this process. The investigators can then assess whether the demand for additional fluid in response to thirst reduces in frequency in proportion to the degree of correction of fluid deficit.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy physically active male volunteers aged 18-65 years.

• Participants must be normotensive (systolic pressure between 90 and 150 mmHg, diastolic pressure between 60 and 90 mmHg).

• Participants greater than 29 years of age will be required to have a 12 lead ECG evaluated by an appropriate IMO prior to participating.

Exclusion Criteria:

• Known cardiovascular disease

• Known renal disease

• Known hepatic disease

• Taking medications which might affect sense of thirst or salt/water handling

• History of heat intolerance

Related Conditions & MeSH terms

• Dehydration
• Dehydration Hypertonic

Intervention

Device:
• Patient controlled fluid device administering high volume thirst guided fluid bolus
The administration of a 200ml fluid bolus in response to subjective thirst. Participant activates trigger in response to thirst which activates fluid pump to deliver 50ml IV fluid bolus of 4% dextrose & 0.18% sodium chloride
• Patient controlled fluid device administering low volume thirst guided fluid bolus
The administration of a 50ml fluid bolus in response to subjective thirst. Participant activates trigger in response to thirst which activates fluid pump to deliver 50ml IV fluid bolus of 4% dextrose & 0.18% sodium chloride

Locations

Country	Name	City	State
United Kingdom	Department of Sport and Exercise Science	Portsmouth

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	University of Portsmouth, University of Wollongong

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Volume	The primary outcome measure is the total volume of fluid administered during the infusion	This will be measured over the 4 hour rehydration infusion