Patient Controlled Fluid Administration

NCT03176043 | Unknown Early Phase 1

• 1 other identifier: 9339/001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dehydration (Physiology); Thirst; Due to Deprivation of Water; Plasma Osmolality Increased; Hypovolemia

Outcome Measures

Primary Outcomes (1)

• Volume of Fluid Administered

  Volume of Fluid Administered, this total volume measured in ml will be logged by the volumetric pump.

  4 hours

Secondary Outcomes (3)

• Change in body mass

  4 hours

• Change in urine specific gravity

  4 hours

• Change in plasma osmolality

  4 hours

Study Arms (2)

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.

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.

Procedure: IV Fluid Administration

Interventions

IV Fluid Administration PROCEDURE

Administration of 4% Dextrose in 0.18% Sodium Chloride, through an IV cannula via a volumetric infusion pump.

NICE infusion; Thirst Driven infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male volunteers, age range of 18-65 years weighing between 60-100 kg,

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Institute of Sport Exercise & Health

London, W1T7HA, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 29406177 DERIVED

MeSH Terms

Conditions

Dehydration; Hypovolemia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Fintan Hughes

CONTACT

0044 773 140 3686; fint@nhugh.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 5, 2017
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 5, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)