The Absorption Rate of Subcutaneous Infused Fluid (ABSU)

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

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.

Study Overview

• Status: Completed
• Conditions: Fluid Therapy; Dehydration; Aged; Aged, 75 and Over; Hypodermoclysis
• Intervention / Treatment: Procedure: Subcutaneous parenteral hydration

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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years to 120 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the local geriatric ward will be screened for eligibility.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Mathias B Danielsen, MD, Aalborg University Hospital

Publications and helpful links

General Publications

• Danielsen MB, Jodal L, Riis J, Karmisholt JS, Valdorsson O, Jorgensen MG, Andersen S. Absorption rate of subcutaneously infused fluid in ill multimorbid older patients. PLoS One. 2022 Oct 10;17(10):e0275783. doi: 10.1371/journal.pone.0275783. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Dehydration; Fluid therapy; Geriatric; Hypodermoclysis; Sodium Pertechnetate Tc 99m
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: N-20200010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification. Data sets will only be shared when the anonymity of included participants can be insured.
• IPD Sharing Time Frame: Beginning 6 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: The dataset will be shared upon reasonable request.
• IPD Sharing Supporting Information Type: Study Protocol; Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No