Aged, 75 and OverABSUNCT04536324
The Absorption Rate of Subcutaneous Infused Fluid
An observational study of Aged, 75 and Over and Aged, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 120 years
- Conditions the study is for
- Aged, 75 and Over, Aged, Hypodermoclysis
- What is being tested?
- Subcutaneous parenteral hydration
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 20 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to the local geriatric ward will be screened for eligibility.
Who may be able to join
- Ability to give informed consent
- Hospitalized for an acute illness
Who cannot join
- Severe limitation on fluids
- Risk of acute deterioration of illness
- Requiring constant care
- Short life expectancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aged, 75 and Over, Aged, Hypodermoclysis, Fluid Therapy, Dehydration
- Being tested
- Subcutaneous parenteral hydration
- Keywords
- Dehydration, Fluid therapy, Hypodermoclysis, Geriatric, Sodium Pertechnetate Tc 99m
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous parenteral hydrationProcedure or surgery
Also called Hypodermoclysis
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks after discharge
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Sep 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aged, 75 and OverStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Aalkjær Brix Danielsen, Aalborg University Hospital
- Investigators
- Mathias B Danielsen, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536324
- Sponsor's protocol ID
- N-20200010
- Acronym
- ABSU
- Status last verified
- Feb 2021
- First submitted
- 28 Aug 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 36215232
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Absorption Rate of Subcutaneous Infused Fluid in Both Acutely Ill and Healthy Older Adults
- ClinicalTrials.gov ID
- NCT04536324
- Acronym / sponsor ID
- ABSU / N-20200010
- Conditions
- Aged, 75 and Over, Aged, Hypodermoclysis, Fluid Therapy, Dehydration
- Keywords
- Dehydration, Fluid therapy, Hypodermoclysis, Geriatric, Sodium Pertechnetate Tc 99m
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to the local geriatric ward will be screened for eligibility.
Key inclusion criteria (2 listed)
- Ability to give informed consent
- Hospitalized for an acute illness
Key exclusion criteria (4 listed)
- Severe limitation on fluids
- Risk of acute deterioration of illness
- Requiring constant care
- Short life expectancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous parenteral hydrationAlso: HypodermoclysisPatients 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. | Procedure or surgery | – |
Primary outcome
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).
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 36215232Danielsen 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias B Danielsen, MD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aged, 75 and Over and Aged, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the absorption rate between acutely ill and not acutely ill. (time frame: 8 weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.