Hypovolemia Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 16 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Healthy male volunteers, age range of 18-65 years weighing between 60-100 kg, Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Institute of Sport Exercise & Health | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volume of Fluid Administered | Volume of Fluid Administered, this total volume measured in ml will be logged by the volumetric pump. | 4 hours | |
Secondary | 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. | 4 hours | |
Secondary | 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. | 4 hours | |
Secondary | 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. | 4 hours |
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