Mathias Brix Danielsen1,2, Elisa Worthington3, Jesper Scott Karmisholt2,4, Jørn Munkhof Møller3, Martin Gronbech Jørgensen1, Stig Andersen1,2. 1. Department of Geriatric Medicine, Aalborg University Hospital, 9000 Aalborg, Denmark. 2. Department of Clinical Medicine, Aalborg University, 9000 Aalborg, Denmark. 3. Department of Emergency Medicine, Aalborg University Hospital, 9000 Aalborg, Denmark. 4. Department of Endocrinology, Aalborg University Hospital, 9000 Aalborg, Denmark.
Abstract
BACKGROUND: Hydration therapy is essential in the care of the older patient. Subcutaneous (SC) hydration is a relevant method for parenteral hydration, but clinical trials on the subject have methodological shortcomings compared to updated standards. DESIGN: Assessor-blinded, non-inferiority RCT to explore if SC is a safe alternative to intravenous (IV) hydration. PARTICIPANTS: Eligible patients were: Admitted patients 65 years or older with a need for parenteral hydration. The targeted sample size was 67 patients in each group. INTERVENTION: Patients were randomised to parenteral hydration via an IV or SC catheter during a 24 hours observation period. The non-randomised catheter (inactive) was placed as a sham on the patient, thereby blinding the caregivers and outcome assessors. MEASUREMENT: Our primary outcome was the proportion of patients reporting at least one adverse effect with a non-inferiority calculation using a 20% margin. RESULTS: We included 51 patients, with 24 randomised to SC and 27 to IV. We were unable to reach our target sample size due to challenges in recruitment, time limitation, and COVID-19. For the outcome of adverse effects, SC was non-inferior to IV (p = 0.012). Time spent on inserting the catheters was shorter with SC (p = 0.001). The groups did not differ by pain of insertion, discomfort during infusion, or the risk of developing delirium. CONCLUSION: SC is a safe alternative to IV hydration, is faster to place and should be an available method for parenteral hydration wherever older adults are cared for. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03710408.
BACKGROUND: Hydration therapy is essential in the care of the older patient. Subcutaneous (SC) hydration is a relevant method for parenteral hydration, but clinical trials on the subject have methodological shortcomings compared to updated standards. DESIGN: Assessor-blinded, non-inferiority RCT to explore if SC is a safe alternative to intravenous (IV) hydration. PARTICIPANTS: Eligible patients were: Admitted patients 65 years or older with a need for parenteral hydration. The targeted sample size was 67 patients in each group. INTERVENTION: Patients were randomised to parenteral hydration via an IV or SC catheter during a 24 hours observation period. The non-randomised catheter (inactive) was placed as a sham on the patient, thereby blinding the caregivers and outcome assessors. MEASUREMENT: Our primary outcome was the proportion of patients reporting at least one adverse effect with a non-inferiority calculation using a 20% margin. RESULTS: We included 51 patients, with 24 randomised to SC and 27 to IV. We were unable to reach our target sample size due to challenges in recruitment, time limitation, and COVID-19. For the outcome of adverse effects, SC was non-inferior to IV (p = 0.012). Time spent on inserting the catheters was shorter with SC (p = 0.001). The groups did not differ by pain of insertion, discomfort during infusion, or the risk of developing delirium. CONCLUSION: SC is a safe alternative to IV hydration, is faster to place and should be an available method for parenteral hydration wherever older adults are cared for. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03710408.