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Subcutaneous vs Intravenous Hydration on Older Adults (SCIV)

Primary Purpose

Dehydration

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intravenous hydration
Subcutaneous hydration
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehydration focused on measuring Hypodermoclysis, Older adults, Geriatric patient, Hydration therapy, Adverse effects, Subcutaneous hydration

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Medical patients admitted to Acute Assessment Unit (AAU). (All internal medicine patients are admitted here first, except highly specialized patients (e.g. ketoacidosis or severe cardiology conditions).
  2. Orthopedic hip fracture patients admitted to the orthopedic ward.
  3. Patients admitted to short term care.
  4. Prescription of 0.5-2 liters of parenteral fluid over the next 24 hours.

Exclusion Criteria:

  1. Red triage tag (severe ill patients)
  2. Prescription of IV antibiotics or other treatment administrate intravenous
  3. Severe dehydration (fluid requirements over 2 liters over 24 hours)
  4. Known strict fluid restriction (cannot receive ½ liters of fluid infusion)
  5. Severe general edema
  6. Unable to give informed consent

Sites / Locations

  • Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subcutaneous hydration

Intravenous hydration

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse effects (dichotomous variable, blinded, non-inferior)
The incidence of adverse effects of hydration therapy (both serious and minor adverse effects) is the primary outcome measure of this study. Serious adverse effects will be defined as any consequence of infusion requiring treatment(e.g. diuretics, analgesic and antibiotics) Minor adverse effects will be defined as any of the following: Reddening of the skin at infusion site larger than what is covered by dressing. Painful swelling at infusion site. Prolonged swelling at infusion site (more than two hours after end of infusion). Itching. Phlebitis without needing treatment. Patient complaining of infusion related pain. Failure of infusion. Need of reinserting the infusion needle. Accidental catheter removal by the patient. Need for reducing of flow speed due to complaint from the patient. Swelling at infusion site, without discomfort or need for action, will not be evaluated as an adverse effect.

Secondary Outcome Measures

Incidence of serious adverse effects (total number of serious adverse effects (discrete variable, blinded)
A sensitivity analysis of the primary outcome comparing only the serious adverse effects.
Incidence of adverse effects (dichotomous variable, blinded, superiority calculation)
Same description as primary outcome, but this calculation will only be performed if non-inferiority is found.
Incidence of adverse effects (total number of adverse effects (discrete variable, not blinded)
Same as description primary outcome but this is a comparison of the number of adverse effects the average patient experience.
Personal graded time spend on insertion of active device (ordered categorical variable, non-blinded).
Nurses will estimate the time of insertion of the active device into the following categories: 1) less than 3 min., 2) 3-5 min, 3) 5-10 min, 4) 10-20 min. If the primary nurse cannot achieve access it will be noted if 5) another ER nurse or an 6) anesthesiological nurse is needed. Lower is better.
Participants evaluation of pain during inserting the active device (continuous variable, non-blinded).
Participants will evaluate the pain of having the active access device inserted on a Visual Analog Scale (VAS) 0-100 mm. Lower is better.
Participants evaluation of pain during fluid infusion through the active device (continuous variable, non-blinded)
Participants will evaluate the pain during infusion (24 hours) on a Visual Analog Scale (VAS) 0-100 mm. Lower is better. This will be done for both the active and sham device.
Presence of delirium (dichotomous variable, blinded)
Number of delirious participants at end of observation adjusted for number of delirious participants at inclusion. The presence of delirium will be evaluated using Confusion Assessment Method (CAM).
Death during hospitalization (dichotomous variable, blinded)
Compare death during hospitalization between groups. Both deaths during the observation period and after the end of observation but still during the same admission.

Full Information

First Posted
June 13, 2018
Last Updated
November 11, 2020
Sponsor
Aalborg University Hospital
Collaborators
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03710408
Brief Title
Subcutaneous vs Intravenous Hydration on Older Adults
Acronym
SCIV
Official Title
Adverse Effects of Subcutaneous vs Intravenous Hydration on Older Acutely Admitted Patients: An Assessor-blinded, Non-inferiority RCT
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the risk of adverse effects of intravenous hydration compared to subcutaneous hydration. Half of the patients will receive hydration by the subcutaneous route the other half by the intravenous route. In the subsequent 24 hours period the patients will be monitored for any sign of adverse effects.
Detailed Description
Adequate hydration is essential to humans, and is tightly regulated in the healthy adult by in- and output (i.e. thirst and urine production). This regulation is often hampered in the geriatric patient due to a decreased sensation of thirst and impaired kidney function. The risk of dehydration increases rapidly in the acutely ill geriatric patient with the growing fluid demand of fever and reduced ability to self-hydrate due to fatigue. Dehydration will often aggravate an acute illness creating a vicious circle. External rehydration is essential to stop or even prevent this downward spiral. Adequate hydration can be maintained or achieved by two different routes: oral intake or parenteral infusion. When oral hydration is insufficient, intravenous (IV) fluid infusion is the commonly used route. However, subcutaneous (SC) infusion of fluid, also known as hypodermoclysis, is an alternative route. Several studies have compared SC hydration to IV hydration with the main outcome being laboratory test of hydration or subjective assessment scores. They all found similar effects on laboratory markers of hydration, which align with the theory of mass conservation. They also found a similar incidence of side effects between IV and SC hydration as secondary outcomes. The main drawback of these studies is methodological shortcomings. The lack of blinding introduces a large risk of bias on subjective outcome such as assessment scores and grading of side effects. Furthermore, the largest of the studies had a third of their patients switch groups diluting the result. A recent Cochrane review on achieving parenteral hydration found that the quality of included trials was low and future trials should prospectively register, have secure allocation concealment, adequate sample sizes and should be reported according to established standard. This study will examine if subcutaneous (SC) hydration is a safe alternative to intravenous (IV) hydration in the geriatric patient in the Emergency Department, Acute Assessment Unit or Orthopedic Ward of Aalborg University Hospital. This will be achived by preforming an assessor-blinded, non-inferior, randomized controlled trial. Relevant participants (see Eligibility Criteria) arriving at Aalborg University Hospital will be enrolled after informed consent. Baseline measurements will be obtained, and the participants will be randomized (1:1) to either intravenous or subcutaneous hydration. A sham setup will be use so both an intravenous access and a subcutaneous access will be visible on the patient, but only one of them will be active. For the next 24 hours the participants will regularly be evaluated by a nurse blinded to infusion for the presence of adverse effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
Hypodermoclysis, Older adults, Geriatric patient, Hydration therapy, Adverse effects, Subcutaneous hydration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
To achieve assessor/care provider blinding, all participants will receive a sham needle (opposite of the randomization). This will not pierce the skin but just lay on top of the skin. Both the randomized and the sham needle will be covered by non-woven swabs before placement of the dressing. Both the active and the sham device is connected to an infusion set. The infusion tubes will be tangled at the top, just below the roller ball and drop counter. The entanglement will be covered by opaque dressing. This way it cannot be know which infusions tube is connected to the fluid bag, while it is still possible to control the infusion speed.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous hydration
Arm Type
Experimental
Arm Title
Intravenous hydration
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Intravenous hydration
Other Intervention Name(s)
BD VenflonTM Pro Safety - 22G
Intervention Description
Participants assigned to the intravenous hydration arm will receive their hydration therapy through an intravenous access. This access will be achieved by inserting a "BD VenflonTM Pro Safety - 22G" in a vein in the dorsal side of the hand or further up the forearm. If the participants is suspected of becoming delirious and at risk of removing the cannula from the hand/forearm, it may be inserted at the dorsal side of the foot. The clinical staff judge this risk and decide site of placement. Furthermore, a sham subcutaneous access device "BD Saf-T-Intima™ Integrated Safety Catheter System" will be placed on the abdomen without piercing the skin.
Intervention Type
Other
Intervention Name(s)
Subcutaneous hydration
Other Intervention Name(s)
BD Saf-T-Intima™ Integrated Safety Catheter System
Intervention Description
Participants assigned to the subcutaneous hydration arm will receive their hydration therapy through a subcutaneous access. This access will be achieved by placing a "BD Saf-T-Intima™ Integrated Safety Catheter System" on the abdomen or, alternatively if the participants is suspected of becoming delirious and at risk of removing the needle, it will be placed on the back at the scapular region. Furthermore, a sham IV access device "BD VenflonTM Pro Safety - 22G" will be placed on the dorsal side of the hand without piercing the skin.
Primary Outcome Measure Information:
Title
Incidence of adverse effects (dichotomous variable, blinded, non-inferior)
Description
The incidence of adverse effects of hydration therapy (both serious and minor adverse effects) is the primary outcome measure of this study. Serious adverse effects will be defined as any consequence of infusion requiring treatment(e.g. diuretics, analgesic and antibiotics) Minor adverse effects will be defined as any of the following: Reddening of the skin at infusion site larger than what is covered by dressing. Painful swelling at infusion site. Prolonged swelling at infusion site (more than two hours after end of infusion). Itching. Phlebitis without needing treatment. Patient complaining of infusion related pain. Failure of infusion. Need of reinserting the infusion needle. Accidental catheter removal by the patient. Need for reducing of flow speed due to complaint from the patient. Swelling at infusion site, without discomfort or need for action, will not be evaluated as an adverse effect.
Time Frame
The participants will be observed for 24 hours after the start of infusion.
Secondary Outcome Measure Information:
Title
Incidence of serious adverse effects (total number of serious adverse effects (discrete variable, blinded)
Description
A sensitivity analysis of the primary outcome comparing only the serious adverse effects.
Time Frame
The participants will be observed for 24 hours after the start of infusion
Title
Incidence of adverse effects (dichotomous variable, blinded, superiority calculation)
Description
Same description as primary outcome, but this calculation will only be performed if non-inferiority is found.
Time Frame
The participants will be observed for 24 hours after the start of infusion.
Title
Incidence of adverse effects (total number of adverse effects (discrete variable, not blinded)
Description
Same as description primary outcome but this is a comparison of the number of adverse effects the average patient experience.
Time Frame
The participants will be observed for 24 hours after the start of infusion.
Title
Personal graded time spend on insertion of active device (ordered categorical variable, non-blinded).
Description
Nurses will estimate the time of insertion of the active device into the following categories: 1) less than 3 min., 2) 3-5 min, 3) 5-10 min, 4) 10-20 min. If the primary nurse cannot achieve access it will be noted if 5) another ER nurse or an 6) anesthesiological nurse is needed. Lower is better.
Time Frame
During procedure.
Title
Participants evaluation of pain during inserting the active device (continuous variable, non-blinded).
Description
Participants will evaluate the pain of having the active access device inserted on a Visual Analog Scale (VAS) 0-100 mm. Lower is better.
Time Frame
During procedure.
Title
Participants evaluation of pain during fluid infusion through the active device (continuous variable, non-blinded)
Description
Participants will evaluate the pain during infusion (24 hours) on a Visual Analog Scale (VAS) 0-100 mm. Lower is better. This will be done for both the active and sham device.
Time Frame
Participants will evaluate this at the end of observation (24 hours after inclusion)
Title
Presence of delirium (dichotomous variable, blinded)
Description
Number of delirious participants at end of observation adjusted for number of delirious participants at inclusion. The presence of delirium will be evaluated using Confusion Assessment Method (CAM).
Time Frame
Duration of observation (24 hours)
Title
Death during hospitalization (dichotomous variable, blinded)
Description
Compare death during hospitalization between groups. Both deaths during the observation period and after the end of observation but still during the same admission.
Time Frame
From inclusion to end of current admission. Cutoff is one month after inclusion.
Other Pre-specified Outcome Measures:
Title
Effect of infusion method on hydration status, evaluated by P-albumin (continuous variables)
Description
A comparison of changes in albumin. We will refrain from performing statistical analysis on the effect of hydration. This is both due to the complexity of evaluating dehydration status on geriatric patients, but also to avoid a type 1 error due to multiple comparisons.
Time Frame
Changes from inclusion to end of observation (24 hours)
Title
Effect of infusion method on hydration status, evaluated by P-creatinine (continuous variables)
Description
A comparison of changes in creatinine. We will refrain from performing statistical analysis on the effect of hydration. This is both due to the complexity of evaluating dehydration status on geriatric patients, but also to avoid a type 1 error due to multiple comparisons.
Time Frame
Changes from inclusion to end of observation (24 hours)
Title
Effect of infusion method on hydration status, evaluated by eGFR (continuous variables)
Description
A comparison of changes in eGFR. We will refrain from performing statistical analysis on the effect of hydration. This is both due to the complexity of evaluating dehydration status on geriatric patients, but also to avoid a type 1 error due to multiple comparisons.
Time Frame
Changes from inclusion to end of observation (24 hours)
Title
Effect of infusion method on hydration status, evaluated by P-urea (continuous variables)
Description
A comparison of changes in urea. We will refrain from performing statistical analysis on the effect of hydration. This is both due to the complexity of evaluating dehydration status on geriatric patients, but also to avoid a type 1 error due to multiple comparisons.
Time Frame
Changes from inclusion to end of observation (24 hours)
Title
Effect of infusion method on hydration status, evaluated by P-osmolality (continuous variables)
Description
A comparison of changes in osmolality. We will refrain from performing statistical analysis on the effect of hydration. This is both due to the complexity of evaluating dehydration status on geriatric patients, but also to avoid a type 1 error due to multiple comparisons.
Time Frame
Changes from inclusion to end of observation (24 hours)
Title
Effect of infusion method on hydration status, evaluated by hemoglobin (continuous variables)
Description
A comparison of changes in hemoglobin. We will refrain from performing statistical analysis on the effect of hydration. This is both due to the complexity of evaluating dehydration status on geriatric patients, but also to avoid a type 1 error due to multiple comparisons.
Time Frame
Changes from inclusion to end of observation (24 hours)
Title
Effect of infusion method on hydration status, evaluated by P-sodium (continuous variables)
Description
A comparison of changes in sodium. We will refrain from performing statistical analysis on the effect of hydration. This is both due to the complexity of evaluating dehydration status on geriatric patients, but also to avoid a type 1 error due to multiple comparisons.
Time Frame
Changes from inclusion to end of observation (24 hours)
Title
Effect of infusion method on hydration status, evaluated by P-potassium (continuous variables)
Description
A comparison of changes in potassium. We will refrain from performing statistical analysis on the effect of hydration. This is both due to the complexity of evaluating dehydration status on geriatric patients, but also to avoid a type 1 error due to multiple comparisons.
Time Frame
Changes from inclusion to end of observation (24 hours)
Title
Effect of infusion method on hydration status, evaluated by blood pressure (both systolic and diastolic will be measured and compared) (continuous variables).
Description
A comparison of changes in blood pressure. We will refrain from performing statistical analysis on the effect of hydration. This is both due to the complexity of evaluating dehydration status on geriatric patients, but also to avoid a type 1 error due to multiple comparisons.
Time Frame
Changes from inclusion to end of observation (24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medical patients admitted to Acute Assessment Unit (AAU). (All internal medicine patients are admitted here first, except highly specialized patients (e.g. ketoacidosis or severe cardiology conditions). Orthopedic hip fracture patients admitted to the orthopedic ward. Patients admitted to short term care. Prescription of 0.5-2 liters of parenteral fluid over the next 24 hours. Exclusion Criteria: Red triage tag (severe ill patients) Prescription of IV antibiotics or other treatment administrate intravenous Severe dehydration (fluid requirements over 2 liters over 24 hours) Known strict fluid restriction (cannot receive ½ liters of fluid infusion) Severe general edema Unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias B Danielsen, MD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification. Data sets will only be share where anonymity of included participants can be insured.
IPD Sharing Time Frame
Beginning 6 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Data will be shared upon reasonable request.
Citations:
PubMed Identifier
8641599
Citation
O'Keeffe ST, Lavan JN. Subcutaneous fluids in elderly hospital patients with cognitive impairment. Gerontology. 1996;42(1):36-9. doi: 10.1159/000213768.
Results Reference
background
PubMed Identifier
8183752
Citation
Challiner YC, Jarrett D, Hayward MJ, al-Jubouri MA, Julious SA. A comparison of intravenous and subcutaneous hydration in elderly acute stroke patients. Postgrad Med J. 1994 Mar;70(821):195-7. doi: 10.1136/pgmj.70.821.195.
Results Reference
background
PubMed Identifier
12558710
Citation
Slesak G, Schnurle JW, Kinzel E, Jakob J, Dietz PK. Comparison of subcutaneous and intravenous rehydration in geriatric patients: a randomized trial. J Am Geriatr Soc. 2003 Feb;51(2):155-60. doi: 10.1046/j.1532-5415.2003.51052.x.
Results Reference
background
PubMed Identifier
25914907
Citation
Ker K, Tansley G, Beecher D, Perner A, Shakur H, Harris T, Roberts I. Comparison of routes for achieving parenteral access with a focus on the management of patients with Ebola virus disease. Cochrane Database Syst Rev. 2015 Feb 26;2015(2):CD011386. doi: 10.1002/14651858.CD011386.pub2.
Results Reference
background
PubMed Identifier
34651171
Citation
Danielsen MB, Worthington E, Karmisholt JS, Moller JM, Jorgensen MG, Andersen S. Adverse effects of subcutaneous vs intravenous hydration in older adults: An assessor-blinded randomised controlled trial (RCT). Age Ageing. 2022 Jan 6;51(1):afab193. doi: 10.1093/ageing/afab193.
Results Reference
derived

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Subcutaneous vs Intravenous Hydration on Older Adults

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