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Subcutaneous vs Intravenous Hydration on Older Adults

NCT ID: NCT03710408

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-20

Study Completion Date

2020-11-01

Brief Summary

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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

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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

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Dehydration

Keywords

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Hypodermoclysis Older adults Geriatric patient Hydration therapy Adverse effects Subcutaneous hydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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Subcutaneous hydration

Group Type EXPERIMENTAL

Subcutaneous hydration

Intervention Type OTHER

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.

Intravenous hydration

Group Type ACTIVE_COMPARATOR

Intravenous hydration

Intervention Type OTHER

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.

Interventions

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Intravenous hydration

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

Subcutaneous hydration

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.

Intervention Type OTHER

Other Intervention Names

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BD VenflonTM Pro Safety - 22G BD Saf-T-Intima™ Integrated Safety Catheter System

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mathias Aalkjær Brix Danielsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mathias B Danielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

References

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O'Keeffe ST, Lavan JN. Subcutaneous fluids in elderly hospital patients with cognitive impairment. Gerontology. 1996;42(1):36-9. doi: 10.1159/000213768.

Reference Type BACKGROUND
PMID: 8641599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8183752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12558710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25914907 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34651171 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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N-20180014

Identifier Type: -

Identifier Source: org_study_id