Clinical trial NCT04536324: The Absorption Rate of Subcutaneous Infused Fluid
Official title: The Absorption Rate of Subcutaneous Infused Fluid in Both Acutely Ill and Healthy Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aged, 75 and Over
Aged
Hypodermoclysis
Fluid Therapy
Dehydration
Keywords: Dehydration
Fluid therapy
Hypodermoclysis
Geriatric
Sodium Pertechnetate Tc 99m
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 6
Sex: ALL
Minimum age (years): 75
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the local geriatric ward will be screened for eligibility.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The difference in the absorption rate between acutely ill and not acutely ill.
timeFrame: 8 weeks after discharge
Secondary outcomes:
measure: The absorption rate of subcutaneous infused fluid by count over the infusion site
timeFrame: We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.
measure: The absorption rate of subcutaneous infused fluid by count in the thyroid or by count in blood samples.
timeFrame: We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.
measure: The correlation between s-albumin and absorption time.
timeFrame: We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Mathias B Danielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.