The Absorption Rate of Subcutaneous Infused Fluid

Aged Clinical Trial

— ABSU  

Official title:

The Absorption Rate of Subcutaneous Infused Fluid in Both Acutely Ill and Healthy Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536324
• Other study ID #: N-20200010
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: February 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Aged, 75 and Over
• Dehydration
• Fluid Therapy
• Hypodermoclysis

Intervention

Procedure:
• Subcutaneous parenteral hydration
Patients will twice receive a subcutaneous infusion of 250 ml isotonic sodium chloride (NaCl) with 30 MBq Tc-99m pertechnetate mixed in. The patients will receive the first infusion during admission to our geriatric ward (when they are acutely ill) and the second infusion approximately 8 weeks after discharge when they are no longer acutely ill. The subcutaneous access will be placed on the abdomen in the lower left or right quadrant.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the absorption rate between acutely ill and not acutely ill.	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).	8 weeks after discharge
Secondary	The absorption rate of subcutaneous infused fluid by count over the infusion site	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.	We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.
Secondary	The absorption rate of subcutaneous infused fluid by count in the thyroid or by count in blood samples.	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.	We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.
Secondary	The correlation between s-albumin and absorption time.	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.	We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.