Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04536324
Other study ID # N-20200010
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date November 20, 2020

Study information

Verified date February 2021
Source Aalborg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date November 20, 2020
Est. primary completion date November 20, 2020
Accepts healthy volunteers No
Gender All
Age group 75 Years to 120 Years
Eligibility 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

Study Design


Intervention

Procedure:
Subcutaneous parenteral hydration
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.

Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 (CAPTUSĀ® 3000, Capintec Inc. Pittsburgh). From this data, we will estimate the absorption rate of the subcutaneous infused fluid. We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.
Secondary 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 (CAPTUSĀ® 3000, Capintec Inc. Pittsburgh) to count the activity in both the thyroid and blood samples.
We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.
Secondary 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. We will count the activity from the start of infusions until 2 hours after all of the 250 ml have been infused.
See also
  Status Clinical Trial Phase
Completed NCT06454071 - Immunologic Changes and Recovery-related Factors in Elderly Colon Cancer Patients Phase 2
Completed NCT03297567 - Physical Therapy Guidelines For Hospitalized Elderly N/A
Completed NCT00404118 - Senior Coordinated Referral Study N/A
Not yet recruiting NCT04419753 - The Role of Attention Focus Walking Training in Older Adults. N/A
Completed NCT03138265 - HIT Training in the Frail Elderly. N/A
Completed NCT02598882 - Virtual Reality as a Tool for Rehabilitation on Elderly People N/A
Completed NCT02598115 - Impact of Collaborative Pharmaceutical Care on Hospital Admission Drug Prescriptions for Patients 65 Years of Age and Older N/A
Completed NCT05447533 - Clostridioides Difficile and Frailty N/A
Completed NCT04127539 - Evaluation of Strong & Steady - Fall Preventive Group Exercise Program N/A
Completed NCT05586828 - A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
Not yet recruiting NCT04516174 - Effect of Transversus Abdominis Plane Block Combined With Dexmedetomidine Infusion on the Prognosis in Elderly Patients Undergoing Abdominal Surgery N/A
Completed NCT02918058 - Reducing Post-discharge Potentially Inappropriate Medications Among Older Adults N/A
Suspended NCT05107947 - Light in Frail Elderly - the Effect of a Dynamic Light for Sleep and Circadian Rhythm N/A
Completed NCT03336177 - Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients.
Completed NCT06095661 - Virtual Reality as a Postoperative Pain Management Adjunct in Older Adults: An Acceptability and Feasibility Study N/A
Completed NCT04715971 - Urinary Retention on an Acute Geriatric Hospitalisation Unit.
Recruiting NCT04327115 - Study of an Physical Exercise Program on Older People of 75 Years Old and More, Hospitalized in Geriatric Short Stay N/A
Recruiting NCT04128410 - A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients
Completed NCT02181062 - Culturally Tailoring a Stroke Intervention in Community Senior Centers N/A
Completed NCT02280928 - Development and Evaluation of a Home-Based Dual-Task Training Program to Improve Balance Performance for Older Adults N/A