The Absorption Rate of Subcutaneous Infused Fluid

Completed

• Conditions: Aged, 75 and Over; Hypodermoclysis; Fluid Therapy; Dehydration; Aged

• Registration Number: NCT04536324
• Lead Sponsor: Aalborg University Hospital

Brief Summary

The purpose of the study is to examine the rate of absorption of subcutaneous infused fluid in older adults when acutely ill compared to when they are not acutely ill.

Detailed Description

Dehydration is a common condition in older adults. When oral hydration is insufficient there is a need for parenteral hydration. Subcutaneous infused fluid or hypodermoclysis is a method for parenteral hydration. This method is used to treat older adults with mild to moderate dehydration or at risk of dehydration. Despite that, this method is used in older adults who are acutely ill we have a very limited understanding of the absorption time and thereby when the infused fluid is available in the circulatory system. This study aims to compare the absorption time in older adults who are acutely ill with when they are not acutely ill. Furthermore, this study aims to describe how fast the subcutaneous infused fluid is absorbed from the subcutaneous space and subsequently when it is available in the circulatory system where it has its effect.

Study Timeline

• Study First Submitted: 2020-08-28
• Study First Submitted QC: 2020-08-28
• Study Start: 2020-09-01
• Study First Posted: 2020-09-02
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Ability to give informed consent
• Hospitalized for an acute illness

Exclusion Criteria

• Severe limitation on fluids
• Risk of acute deterioration of illness
• Requiring constant care
• Short life expectancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in the absorption rate between acutely ill and not acutely ill.	8 weeks after discharge	We will compare the absorptions rate of subcutaneous infused fluid when the patients are acutely ill (during admission) and when they are not acutely ill (8 weeks after discharge).

Secondary Outcome Measures

Name	Time	Method
The absorption rate of subcutaneous infused fluid by count over the infusion site	We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.	From the start of the infusion, we will count the activity with a gamma detector (CAPTUS® 3000, Capintec Inc. Pittsburgh). From this data, we will estimate the absorption rate of the subcutaneous infused fluid.
The correlation between s-albumin and absorption time.	We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.	As albumin is an important contributor of the osmotic pressure of serum we will in investigate if there is a correlation between the level of s-albumin and absorption rate.
The absorption rate of subcutaneous infused fluid by count in the thyroid or by count in blood samples.	We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.	We will also assess the absorption of the subcutaneously infused fluid by registering the activity in the patients' thyroid gland. If the activity in the thyroid is to low to properly register we will measure the activity in the patients' blood samples.; We will use a gamma detector (CAPTUS® 3000, Capintec Inc. Pittsburgh) to count the activity in both the thyroid and blood samples.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark