NCT03959930

Transdermal Fluid Removal in Fluid Overload

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal.

Detailed description

Fluid overload is distressing and is particularly prevalent in patients with vital organ dysfunction such as in kidney and heart disease. Due to the patient's inability to remove excess wastes and water, these accumulate in their body fluid compartments. Such excess fluid and toxins have to be removed with high dose diuretics (water tablets or injections) or by frequent dialysis. Treatment with diuretics is effective initially in some patients but is fraught with risks and side effects. The retained fluid and wastes are mainly lodged within the extracellular compartment (interstitial or tissue fluid) and exert deleterious effects on cell functions. Much of this excess fluid collects relatively superficially within the skin, especially in the lower extremities or other dependent body parts as oedema. The proposed study seeks to explore the possibility of significantly increasing the success rate (from the current rate of 28%) of clinically significant Transdermal Fluid Removal (TFR) in heart failure patients. It seeks to further understand the device and patient characteristics influencing successful clinically relevant fluid removal and to measure any patient-defined benefits. It also wishes to explore the patient experience of the removal. Principal aim of the research: To investigate whether the TFR device can remove clinically viable or relevant volumes of fluid transdermally in advanced heart failure and other patients with significant oedema. "Clinically viable" volume is defined as the removal of 200ml or more of fluid in a session of up to 10 hours (or 0.43 ml/h per 1cm2 of the skin area treated with microneedles).

Conditions

• Heart Failure
• Odema

Interventions

Type	Name	Description
DEVICE	Transdermal Fluid Removal	The Transdermal Fluid Removal (TFR) device is designed for use on the lower limbs of patients with Chronic Heart Failure and treatment resistant peripheral oedema. The TFR device is intended to be applied on oedematous skin of eligible patients, for periods of up to 10 hours at a time, to gently remove excess fluid through the skin, over a period of a few days during exacerbations, thereby avoiding hospitalisation for intravenous diuretics. The TFR device is designed to be used in conjunction with standard Negative Pressure Wound Therapy (NPWT) devices which are currently CE Marked and approved for use in both acute and homecare environment.

Timeline

• Start date: 2020-11-11
• Primary completion: 2022-03-14
• Completion: 2022-03-14
• First posted: 2019-05-22
• Last updated: 2022-06-01

Locations

1 site across 1 country: United Kingdom