Dehydration (Physiology)Early Phase 1NCT03176043
Patient Controlled Fluid Administration
A Early Phase 1 study testing IV Fluid Administration in people with Dehydration (Physiology) and Thirst; Due to Deprivation of Water, run by University College, London at 1 site in United Kingdom.
Trial summary
The purpose of the study is to determine whether participants who are dictating their own administration of IV fluid boluses in response to thirst, receive better protection from hypovolaemia and volume overload than those who undergo routine fluid management. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydration (Physiology), Thirst; Due to Deprivation of Water, Plasma Osmolality Increased
- What is being tested?
- IV Fluid Administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2016to Aug 2017
- Phase
- Early Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteers, age range of 18-65 years weighing between 60-100 kg,
Who cannot join
- Individuals will not be allowed to take part in the study if health screening reveals any cardiovascular, respiratory, renal or metabolic disorder, or identifies any contraindication to Furosemide administration. Furthermore, individuals presenting at the laboratory with febrile symptoms will not be allowed to take part in the study until the fever subsides. During the period of study, individuals will not be allowed to take medications other than those stated in the study protocol and will be excluded if avoiding medication conflicts with previous medical advice.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Sport Exercise & Health
London, W1T7HA
Hugh Montgomery, MB BS
About this study
Official title: Could Thirst-triggered Self-administration of Intravenous Fluid Lead to More Rapid Rehydration Than Clinician-directed Infusion?
The purpose of the study is to determine whether participants who are dictating their own administration of IV fluid boluses in response to thirst, receive better protection from hypovolaemia and volume overload than those who undergo routine fluid management.
Thirst is prominent in critically ill patients and is related to dehydration. In a recent study of the symptoms experience in ITU patients at high risk of dying, the sensation of thirst was reported in 70.8% of assessments made and was considered to be one of the most intense stressors. Thirst and dehydration can be combated in an ITU setting by consuming oral fluids and through administration of intravenous fluids. However, in older adults, frailty and dysphagia reduces patients' capability to access fluid and results in thirst. In addition, the administration of IV fluids is determined by the attending physician and is often only re-evaluated on a daily or twice-daily basis.
Read more
The Quench machine has been designed to allow the patient to have more control over their oral and IV fluid administration protocol. This may help reduce the sensation of thirst and dehydration in patients. The machinery is an automated fluid delivery system that will administer a given bolus of IV fluid in response to a trigger provided by the patient.
The purpose of the current study is to examine the physiological basis for the functional benefit of this Quench system by investigating the effectiveness of the thirst response in healthy humans as a guide for administration of intravenous fluid boluses.
To explore this, the investigators have designed a randomised, cross-over study. On one visit IV fluid boluses will be administered as per the participants' request in response to thirst. In the second arm of the study participants will be administered routine IV fluid maintenance as per NICE guidelines. Body mass at the end of a 4 hour fluid administration intervention will be our primary research outcome and will be compared between the two arms of the study.
From this comparison the investigators hope to show that a patient would be able to accurately manage their level of hydration, both in terms of correcting dehydration and avoiding fluid overload. It is thought that avoiding states of fluid imbalance can reduce post surgical recovery times, reduce the incidence of post operative complications and avoid critical complications of fluid imbalance, such as acute kidney injury.
Read the detailed description
The purpose of the study is to investigate whether participant dictated fluid bolus administration in response to their symptom of experienced thirst is a viable basis to guide a clinical practice of fluid maintenance and correction of hydration status. To this end the experiment will compare the implementation of this fluid maintenance mechanism on volume depleted healthy participants to a program of routine fluid maintenance.
The null hypothesis is that the hydration state of the participants, as measured by change in body weight and plasma osmolality, will be no better corrected and managed by a thirst dictated management system than by routine maintenance.
The study has a cross-over design, used to ensure differences in hydration status, or lack there of, can be attributed to the methods of fluid administration in question, without differences between individuals confounding the results.
The participants will be required to attend the laboratory on two occasions for approximately 5 hours each visit, for arm A and B of the study. The two visits will be separated by 7 to 14 days. On each visit standard IV fluids will be administered The evening before each visit participants will be required to take 40mg of the water tablet called furosemide and refrain from drinking fluids. This is used in order to dehydrate the participant and reduce body mass by between 2 - 4%. The participant needs to be dehydrated in order to promote a thirst response so that the interventions can be studied in a cohort of participants representative of hypovolemic patients post surgery
On both visits an indwelling cannula will be placed into a vein in the participants' arm, to administer IV fluid on the participants' non dominant side. Before fluid administration this will be used to draw a blood sample for plasma osmolality measurements. A second blood sample with be drawn from a vein on the opposite arm following the fluid infusion.
For arm A: the participant will request the administration of 200ml boluses of IV fluid at any point that they experience thirst. This administration will be limited to one bolus every 15 minutes.
For arm B: participants will receive routine fluid maintenance as dictated by the NICE guidelines.
During both trials, low intensity exercise will be permitted (walking, standing, sitting) although high intensity exercise is not allowed. Entertainment in the form of a computer with internet access and DVDs will be provided.
The arm of the study the patient will undergo in the first week will be determined according to a randomised list. However, due to the nature of the investigation the arm of the study be undergone by the patient can not be blinded from the researchers or participant. All measurements, except the perception of thirst questioning, are objective measures, such as weight, plasma osmolality, haematocrit and blood sodium levels. This will minimise any researcher bias.
- Conditions
- Dehydration (Physiology), Thirst; Due to Deprivation of Water, Plasma Osmolality Increased, Hypovolemia
- Being tested
- IV Fluid Administration
- Medical subject headings
- Dehydration, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Fluid AdministrationProcedure or surgery
Administration of 4% Dextrose in 0.18% Sodium Chloride, through an IV cannula via a volumetric infusion pump.
| Study group | Role | What they receive |
|---|---|---|
| Thirst Driven infusion | Experimental | Subjects who are self administering fluid will be instructed when (at any point in the experiment) they are experiencing thirst to request a fluid bolus with an electronic trigger. In response to this trigger the researcher will then deliver a 200ml bolus of IV fluid. After delivery of the fluid bolus, a lockout period is set for 15mins within which the researcher will not deliver another bolus in response to the trigger. Receives: Procedure: IV Fluid Administration |
| NICE infusion | Active comparator | Subjects receiving standard fluid maintenance will receive a baseline infusion rate of 30 mL/kg/24hr (1.25 mL/kg/hr). In addition to this a 500 mL bolus will be delivered if any of the following clinical signs, indicating hypovolaemia, are observed on regular examination: low peripheral perfusion, heart rate >90 /min, systolic BP <100 mmHg, respiratory rate >20, peripheral capillary refill >2sec. A maximum of 2000 mL of fluid will be delivered by additional boluses. Receives: Procedure: IV Fluid Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Fluid Administered
Volume of Fluid Administered, this total volume measured in ml will be logged by the volumetric pump.
Measured: 4 hours
Secondary outcomes (3)
Change in body mass
Change in body mass from the beginning to the end of each infusion. Measured as the subject stands on an electronic scale. Any urine output will we weighed in containers and added to the final mass.
Measured: 4 hours
Change in urine specific gravity
Change in urine specific gravity from the beginning to the end of each infusion. Urine samples taken at the beginning of the study and at the end (subjects having emptied their bladders 30 minutes prior) will be dipped to measure specific gravity.
Measured: 4 hours
Change in plasma osmolality
Change in plasma osmolality in the blood samples drawn at the beginning and end of each infusion. Samples will be centrifuged before being analysed by freezing point depression.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Aug 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (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 (Physiology)Studies 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fintan Hughes, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176043
- Sponsor's protocol ID
- 9339/001
- Status last verified
- Jun 2017
- First submitted
- 30 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hughes F, Ng SC, Mythen M, Montgomery H. Could patient-controlled thirst-driven fluid administration lead to more rapid rehydration than clinician-directed fluid management? An early feasibility study. Br J Anaesth. 2018 Feb;120(2):284-290. doi: 10.1016/j.bja.2017.11.077. Epub 2017 Dec 2.
PubMed 29406177
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Thirst-triggered Self-administration of Intravenous Fluid Lead to More Rapid Rehydration Than Clinician-directed Infusion?
- ClinicalTrials.gov ID
- NCT03176043
- Acronym / sponsor ID
- 9339/001
- Conditions
- Dehydration (Physiology), Thirst; Due to Deprivation of Water, Plasma Osmolality Increased, Hypovolemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 5 Jun 2017 (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.
The purpose of the study is to determine whether participants who are dictating their own administration of IV fluid boluses in response to thirst, receive better protection from hypovolaemia and volume overload than those who undergo routine fluid management.
Thirst is prominent in critically ill patients and is related to dehydration. In a recent study of the symptoms experience in ITU patients at high risk of dying, the sensation of thirst was reported in 70.8% of assessments made and was considered to be one of the most intense stressors. Thirst and dehydration can be combated in an ITU setting by consuming oral fluids and through administration of intravenous fluids. However, in older adults, frailty and dysphagia reduces patients' capability to access fluid and results in thirst. In addition, the administration of IV fluids is determined by the attending physician and is often only re-evaluated on a daily or twice-daily basis.
The Quench machine has been designed to allow the patient to have more control over their oral and IV fluid administration protocol. This may help reduce the sensation of thirst and dehydration in patients. The machinery is an automated fluid delivery system that will administer a given bolus of IV fluid in response to a trigger provided by the patient.
The purpose of the current study is to examine the physiological basis for the functional benefit of this Quench system by investigating the effectiveness of the thirst response in healthy humans as a guide for administration of intravenous fluid boluses.
To explore this, the investigators have designed a randomised, cross-over study. On one visit IV fluid boluses will be administered as per the participants' request in response to thirst. In the second arm of the study participants will be administered routine IV fluid maintenance as per NICE guidelines. Body mass at the end of a 4 hour fluid administration intervention will be our primary research outcome and will be compared between the two arms of the study.
From this comparison the investigators hope to show that a patient would be able to accurately manage their level of hydration, both in terms of correcting dehydration and avoiding fluid overload. It is thought that avoiding states of fluid imbalance can reduce post surgical recovery times, reduce the incidence of post operative complications and avoid critical complications of fluid imbalance, such as acute kidney injury.
Detailed description
The purpose of the study is to investigate whether participant dictated fluid bolus administration in response to their symptom of experienced thirst is a viable basis to guide a clinical practice of fluid maintenance and correction of hydration status. To this end the experiment will compare the implementation of this fluid maintenance mechanism on volume depleted healthy participants to a program of routine fluid maintenance.
The null hypothesis is that the hydration state of the participants, as measured by change in body weight and plasma osmolality, will be no better corrected and managed by a thirst dictated management system than by routine maintenance.
The study has a cross-over design, used to ensure differences in hydration status, or lack there of, can be attributed to the methods of fluid administration in question, without differences between individuals confounding the results.
The participants will be required to attend the laboratory on two occasions for approximately 5 hours each visit, for arm A and B of the study. The two visits will be separated by 7 to 14 days. On each visit standard IV fluids will be administered The evening before each visit participants will be required to take 40mg of the water tablet called furosemide and refrain from drinking fluids. This is used in order to dehydrate the participant and reduce body mass by between 2 - 4%. The participant needs to be dehydrated in order to promote a thirst response so that the interventions can be studied in a cohort of participants representative of hypovolemic patients post surgery
On both visits an indwelling cannula will be placed into a vein in the participants' arm, to administer IV fluid on the participants' non dominant side. Before fluid administration this will be used to draw a blood sample for plasma osmolality measurements. A second blood sample with be drawn from a vein on the opposite arm following the fluid infusion.
For arm A: the participant will request the administration of 200ml boluses of IV fluid at any point that they experience thirst. This administration will be limited to one bolus every 15 minutes.
For arm B: participants will receive routine fluid maintenance as dictated by the NICE guidelines.
During both trials, low intensity exercise will be permitted (walking, standing, sitting) although high intensity exercise is not allowed. Entertainment in the form of a computer with internet access and DVDs will be provided.
The arm of the study the patient will undergo in the first week will be determined according to a randomised list. However, due to the nature of the investigation the arm of the study be undergone by the patient can not be blinded from the researchers or participant. All measurements, except the perception of thirst questioning, are objective measures, such as weight, plasma osmolality, haematocrit and blood sodium levels. This will minimise any researcher bias.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thirst Driven infusion | Experimental | Procedure: IV Fluid AdministrationSubjects who are self administering fluid will be instructed when (at any point in the experiment) they are experiencing thirst to request a fluid bolus with an electronic trigger. In response to this trigger the researcher will then deliver a 200ml bolus of IV fluid. After delivery of the fluid bolus, a lockout period is set for 15mins within which the researcher will not deliver another bolus in response to the trigger. |
| NICE infusion | Active comparator | Procedure: IV Fluid AdministrationSubjects receiving standard fluid maintenance will receive a baseline infusion rate of 30 mL/kg/24hr (1.25 mL/kg/hr). In addition to this a 500 mL bolus will be delivered if any of the following clinical signs, indicating hypovolaemia, are observed on regular examination: low peripheral perfusion, heart rate >90 /min, systolic BP <100 mmHg, respiratory rate >20, peripheral capillary refill >2sec. A maximum of 2000 mL of fluid will be delivered by additional boluses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male volunteers, age range of 18-65 years weighing between 60-100 kg,
Key exclusion criteria (1 listed)
- Individuals will not be allowed to take part in the study if health screening reveals any cardiovascular, respiratory, renal or metabolic disorder, or identifies any contraindication to Furosemide administration. Furthermore, individuals presenting at the laboratory with febrile symptoms will not be allowed to take part in the study until the fever subsides. During the period of study, individuals will not be allowed to take medications other than those stated in the study protocol and will be excluded if avoiding medication conflicts with previous medical advice.
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 |
|---|---|---|
| IV Fluid AdministrationAdministration of 4% Dextrose in 0.18% Sodium Chloride, through an IV cannula via a volumetric infusion pump. | Procedure or surgery | NICE infusion, Thirst Driven infusion |
Primary outcome
Volume of Fluid Administered
Time frame: 4 hours
Volume of Fluid Administered, this total volume measured in ml will be logged by the volumetric pump.
3 secondary outcomes
Change in body mass
Time frame: 4 hours
Change in urine specific gravity
Time frame: 4 hours
Change in plasma osmolality
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Derived from this study: PubMed 29406177Hughes F, Ng SC, Mythen M, Montgomery H. Could patient-controlled thirst-driven fluid administration lead to more rapid rehydration than clinician-directed fluid management? An early feasibility study. Br J Anaesth. 2018 Feb;120(2):284-290. doi: 10.1016/j.bja.2017.11.077. Epub 2017 Dec 2.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IV Fluid Administration in people with Dehydration (Physiology) and Thirst; Due to Deprivation of Water, 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 1 inclusion and 1 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 5 Jun 2017. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Fintan Hughes (0044 773 140 3686, fint@nhugh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of Fluid Administered (time frame: 4 hours). 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 NCT03176043, 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 5 Jun 2017.