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Completed

NCT Number: NCT04536324

The Absorption Rate of Subcutaneous Infused Fluid

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.

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Key information

Conditions

Aged, 75 and Over Aged Dehydration Fluid Therapy Hypodermoclysis Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

75 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subcutaneous parenteral hydration

Procedure

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.

Other names: Hypodermoclysis

Primary outcomes

  1. The difference in the absorption rate between acutely ill and not acutely ill.

    Time frame: 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 outcomes

  1. The absorption rate of subcutaneous infused fluid by count over the infusion site

    Time frame: 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.

  2. The absorption rate of subcutaneous infused fluid by count in the thyroid or by count in blood samples.

    Time frame: 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.

  3. The correlation between s-albumin and absorption time.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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

Acronym: ABSU

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2020
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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