ABSU: The Absorption Rate of Subcutaneous Infused Fluid

Sponsor
Aalborg University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04536324
Collaborator
(none)
6
1
2.6
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
6 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Absorption Rate of Subcutaneous Infused Fluid in Both Acutely Ill and Healthy Older Adults
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Nov 20, 2020
Actual Study Completion Date :
Nov 20, 2020

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aalborg University Hospital Aalborg Denmark

Sponsors and Collaborators

  • Aalborg University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mathias Aalkjær Brix Danielsen, MD, Aalborg University Hospital
ClinicalTrials.gov Identifier:
NCT04536324
Other Study ID Numbers:
  • N-20200010
First Posted:
Sep 2, 2020
Last Update Posted:
Feb 4, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mathias Aalkjær Brix Danielsen, MD, Aalborg University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2021