DehydrationSCIVNCT03710408
Subcutaneous vs Intravenous Hydration on Older Adults
A study testing Intravenous hydration and Subcutaneous hydration in people with Dehydration, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dehydration
- What is being tested?
- Intravenous hydration and Subcutaneous hydration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jan 2019to 1 Nov 2020
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adverse Effects of Subcutaneous vs Intravenous Hydration on Older Acutely Admitted Patients: An Assessor-blinded, Non-inferiority RCT
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.
Read the 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.
- Conditions
- Dehydration
- Being tested
- Intravenous hydration, Subcutaneous hydration
- Keywords
- Hypodermoclysis, Older adults, Geriatric patient, Hydration therapy, Adverse effects, Subcutaneous hydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous hydrationOther
Also called BD VenflonTM Pro Safety - 22G
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.
Subcutaneous hydrationOther
Also called BD Saf-T-Intima™ Integrated Safety Catheter System
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.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous hydration | Experimental | Not described Receives: Other: Subcutaneous hydration |
| Intravenous hydration | Active comparator | Not described Receives: Other: Intravenous hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The participants will be observed for 24 hours after the start of infusion.
Secondary outcomes (8)
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.
Measured: The participants will be observed for 24 hours after the start of infusion
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.
Measured: The participants will be observed for 24 hours after the start of infusion.
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.
Measured: The participants will be observed for 24 hours after the start of infusion.
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.
Measured: During procedure.
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.
Measured: During procedure.
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.
Measured: Participants will evaluate this at the end of observation (24 hours after inclusion)
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).
Measured: Duration of observation (24 hours)
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.
Measured: From inclusion to end of current admission. Cutoff is one month after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start20 Jan 2019
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- 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
- NCT03710408
- Sponsor's protocol ID
- N-20180014
- Acronym
- SCIV
- Status last verified
- Nov 2020
- First submitted
- 13 Jun 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 share where anonymity of included participants can be insured.
Publications
O'Keeffe ST, Lavan JN. Subcutaneous fluids in elderly hospital patients with cognitive impairment. Gerontology. 1996;42(1):36-9. doi: 10.1159/000213768.
PubMed 8641599Challiner 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.
PubMed 8183752Slesak 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.
PubMed 12558710Ker 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.
PubMed 25914907Danielsen 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.
PubMed 34651171
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Effects of Subcutaneous vs Intravenous Hydration on Older Acutely Admitted Patients: An Assessor-blinded, Non-inferiority RCT
- ClinicalTrials.gov ID
- NCT03710408
- Acronym / sponsor ID
- SCIV / N-20180014
- Conditions
- Dehydration
- Keywords
- Hypodermoclysis, Older adults, Geriatric patient, Hydration therapy, Adverse effects, Subcutaneous hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 18 Oct 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous hydration | Experimental | Other: Subcutaneous hydration |
| Intravenous hydration | Active comparator | Other: Intravenous hydration |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Intravenous hydrationAlso: BD VenflonTM Pro Safety - 22GParticipants 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. | Other | Intravenous hydration |
| Subcutaneous hydrationAlso: BD Saf-T-Intima™ Integrated Safety Catheter SystemParticipants 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. | Other | Subcutaneous hydration |
Primary outcome
Incidence of adverse effects (dichotomous variable, blinded, non-inferior)
Time frame: The participants will be observed for 24 hours after the start of infusion.
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.
8 secondary outcomes
Incidence of serious adverse effects (total number of serious adverse effects (discrete variable, blinded)
Time frame: The participants will be observed for 24 hours after the start of infusion
Incidence of adverse effects (dichotomous variable, blinded, superiority calculation)
Time frame: The participants will be observed for 24 hours after the start of infusion.
Incidence of adverse effects (total number of adverse effects (discrete variable, not blinded)
Time frame: The participants will be observed for 24 hours after the start of infusion.
Personal graded time spend on insertion of active device (ordered categorical variable, non-blinded).
Time frame: During procedure.
Participants evaluation of pain during inserting the active device (continuous variable, non-blinded).
Time frame: During procedure.
Participants evaluation of pain during fluid infusion through the active device (continuous variable, non-blinded)
Time frame: Participants will evaluate this at the end of observation (24 hours after inclusion)
Presence of delirium (dichotomous variable, blinded)
Time frame: Duration of observation (24 hours)
Death during hospitalization (dichotomous variable, blinded)
Time frame: From inclusion to end of current admission. Cutoff is one month after inclusion.
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 13 Nov 2020.
- Background: PubMed 8641599O'Keeffe ST, Lavan JN. Subcutaneous fluids in elderly hospital patients with cognitive impairment. Gerontology. 1996;42(1):36-9. doi: 10.1159/000213768.
- Background: PubMed 8183752Challiner 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.
- Background: PubMed 12558710Slesak 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.
- Background: PubMed 25914907Ker 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.
- Derived from this study: PubMed 34651171Danielsen 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.
- Individual participant dataSharing planned: Yes. 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.
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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?
A study testing Intravenous hydration and Subcutaneous hydration in people with Dehydration, 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 4 inclusion and 6 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 13 Nov 2020. 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?
Incidence of adverse effects (dichotomous variable, blinded, non-inferior) (time frame: The participants will be observed for 24 hours after the start of infusion.). 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 NCT03710408, which also lists 5 linked publications.
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 13 Nov 2020.