The Absorption Rate of Subcutaneous Infused Fluid

NCT04536324 | Completed DMC

• 1 other identifier: N-20200010
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dehydration; Fluid therapy; Hypodermoclysis; Geriatric; Sodium Pertechnetate Tc 99m

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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.

• 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.

Interventions

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.

Also known as: Hypodermoclysis

Eligibility Criteria

• Age: 75 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Ability to give informed consent
• Hospitalized for an acute illness

You may not qualify if:

• Severe limitation on fluids
• Risk of acute deterioration of illness
• Requiring constant care
• Short life expectancy

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36215232 DERIVED

MeSH Terms

Conditions

Dehydration

Interventions

Hypodermoclysis

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infusions, Subcutaneous; Infusions, Parenteral; Drug Administration Routes; Drug Therapy; Therapeutics; Fluid Therapy

Study Officials

• Mathias B Danielsen, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 2, 2020
• Study Start: September 1, 2020
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Beginning 6 months and ending 5 years following article publication.
• Access Criteria: The dataset will be shared upon reasonable request.

Locations

DK (1)