Dehydration HypertonicNCT03932890
Thirst-guided Subject-controlled Rehydration in Healthy Volunteers
A study of Dehydration Hypertonic, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration Hypertonic
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jul 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Sport and Exercise Science
Portsmouth, PO1 2UP
About this study
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.
- Conditions
- Dehydration Hypertonic
- Being tested
- Patient controlled fluid device administering high volume thirst guided fluid bolus, Patient controlled fluid device administering low volume thirst guided fluid bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient controlled fluid device administering high volume thirst guided fluid bolusDevice
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 bolusDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Lower Volume fluid bolus arm | Active comparator | The 'lower volume' (LV) fluid bolus arm will receive a continuous background infusion of 4% dextrose in 0.18% NaCl at 50ml/hr for the entire 4 hour rehydration period. Subjects will be given a hand-held trigger, which when pressed will deliver an additional volume of fluid from the infusion pump; this will be administered over a 10-minute period (thus allowing a maximum of 6 boluses per hour). In the LV arm, the trigger will deliver 50mls over 10 mins at a rate of 300ml h-1. A green LED will signal to the patient that no additional infusion is running, and that pressing the trigger will activate delivery of another bolus. The volume and lockout periods for the boluses may vary but will remain within the maximum fluid administration of 1200mls per hour. Receives: Device: Patient controlled fluid device administering low volume thirst guided fluid bolus |
| Higher Volume fluid bolus arm | Experimental | The 'higher volume' (HV) fluid bolus arm will receive a continuous background infusion of 4% dextrose in 0.18% NaCl at 50ml/hr for the entire 4 hour rehydration period. Subjects will be given a hand-held trigger, which when pressed will deliver an additional volume of fluid from the infusion pump; this will be administered over a 10-minute period (thus allowing a maximum of 6 boluses per hour). In the HV arm, the trigger will deliver 200mls over 10 mins at a rate of 1200ml h-1. A green LED will signal to the patient that no additional infusion is running, and that pressing the trigger will activate delivery of another bolus. The volume and lockout periods for the boluses may vary but will remain within the maximum fluid administration of 1200mls per hour. Receives: Device: Patient controlled fluid device administering high volume thirst guided fluid bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Volume
The primary outcome measure is the total volume of fluid administered during the infusion
Measured: This will be measured over the 4 hour rehydration infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start17 Jul 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dehydration HypertonicStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Portsmouth, University of Wollongong
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932890
- Sponsor's protocol ID
- SFEC 2018-053A
- Status last verified
- Jul 2018
- First submitted
- 6 Jul 2018
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data other than final aggregate results will be available to other researchers
Publications
Lacey J, Corbett J, Shepherd A, Dubois A, Hughes F, White D, Tipton M, Mythen M, Montgomery H. Thirst-guided participant-controlled intravenous fluid rehydration: a single blind, randomised crossover study. Br J Anaesth. 2020 Apr;124(4):403-410. doi: 10.1016/j.bja.2019.12.008. Epub 2020 Feb 1.
PubMed 32014238
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thirst-guided Subject-controlled Rehydration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03932890
- Acronym / sponsor ID
- SFEC 2018-053A
- Conditions
- Dehydration Hypertonic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Portsmouth, University of Wollongong
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Volume fluid bolus arm | Active comparator | Device: Patient controlled fluid device administering low volume thirst guided fluid bolusThe 'lower volume' (LV) fluid bolus arm will receive a continuous background infusion of 4% dextrose in 0.18% NaCl at 50ml/hr for the entire 4 hour rehydration period. Subjects will be given a hand-held trigger, which when pressed will deliver an additional volume of fluid from the infusion pump; this will be administered over a 10-minute period (thus allowing a maximum of 6 boluses per hour). In the LV arm, the trigger will deliver 50mls over 10 mins at a rate of 300ml h-1. A green LED will signal to the patient that no additional infusion is running, and that pressing the trigger will activate delivery of another bolus. The volume and lockout periods for the boluses may vary but will remain within the maximum fluid administration of 1200mls per hour. |
| Higher Volume fluid bolus arm | Experimental | Device: Patient controlled fluid device administering high volume thirst guided fluid bolusThe 'higher volume' (HV) fluid bolus arm will receive a continuous background infusion of 4% dextrose in 0.18% NaCl at 50ml/hr for the entire 4 hour rehydration period. Subjects will be given a hand-held trigger, which when pressed will deliver an additional volume of fluid from the infusion pump; this will be administered over a 10-minute period (thus allowing a maximum of 6 boluses per hour). In the HV arm, the trigger will deliver 200mls over 10 mins at a rate of 1200ml h-1. A green LED will signal to the patient that no additional infusion is running, and that pressing the trigger will activate delivery of another bolus. The volume and lockout periods for the boluses may vary but will remain within the maximum fluid administration of 1200mls per hour. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient controlled fluid device administering high volume thirst guided fluid bolusThe 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 | Device | Higher Volume fluid bolus arm |
| Patient controlled fluid device administering low volume thirst guided fluid bolusThe 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 | Device | Lower Volume fluid bolus arm |
Primary outcome
Total Volume
Time frame: This will be measured over the 4 hour rehydration infusion
The primary outcome measure is the total volume of fluid administered during the infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Derived from this study: PubMed 32014238Lacey J, Corbett J, Shepherd A, Dubois A, Hughes F, White D, Tipton M, Mythen M, Montgomery H. Thirst-guided participant-controlled intravenous fluid rehydration: a single blind, randomised crossover study. Br J Anaesth. 2020 Apr;124(4):403-410. doi: 10.1016/j.bja.2019.12.008. Epub 2020 Feb 1.
- Individual participant dataSharing planned: No. No data other than final aggregate results will be available to other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dehydration Hypertonic, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Volume (time frame: This will be measured over the 4 hour rehydration infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.