Subcutaneous vs Intravenous Hydration on Older Adults

NCT03710408 | Completed

• 1 other identifier: N-20180014
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration

Keywords

Hypodermoclysis; Older adults; Geriatric patient; Hydration therapy; Adverse effects; Subcutaneous hydration

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  The participants will be observed for 24 hours after the start of infusion

• Incidence of adverse effects (dichotomous variable, blinded, superiority calculation)

  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)

  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).

  During procedure.

• Participants evaluation of pain during inserting the active device (continuous variable, non-blinded).

  During procedure.

Other Outcomes (9)

• Effect of infusion method on hydration status, evaluated by P-albumin (continuous variables)

  Changes from inclusion to end of observation (24 hours)

• Effect of infusion method on hydration status, evaluated by P-creatinine (continuous variables)

  Changes from inclusion to end of observation (24 hours)

• Effect of infusion method on hydration status, evaluated by eGFR (continuous variables)

  Changes from inclusion to end of observation (24 hours)

Study Arms (2)

Subcutaneous hydration

EXPERIMENTAL

Other: Subcutaneous hydration

Intravenous hydration

ACTIVE COMPARATOR

Other: Intravenous hydration

Interventions

Intravenous hydration 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.

Also known as: BD VenflonTM Pro Safety - 22G

Intravenous hydration

Subcutaneous hydration 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.

Also known as: BD Saf-T-Intima™ Integrated Safety Catheter System

Subcutaneous hydration

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (5)

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

  PMID: 8641599 BACKGROUND

• 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.

  PMID: 8183752 BACKGROUND

• 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.

  PMID: 12558710 BACKGROUND

• 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.

  PMID: 25914907 BACKGROUND

• 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.

  PMID: 34651171 DERIVED

MeSH Terms

Conditions

Dehydration

Interventions

Hypodermoclysis

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infusions, Subcutaneous; Infusions, Parenteral; Drug Administration Routes; Drug Therapy; Therapeutics; Fluid Therapy

Study Officials

• Mathias B Danielsen, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: October 18, 2018
• Study Start: January 20, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Beginning 6 months and ending 5 years following article publication.
• Access Criteria: Data will be shared upon reasonable request.

Locations

DK (1)