At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adverse Effects of Subcutaneous vs Intravenous Hydration on Older Acutely Admitted Patients: An Assessor-blinded, Non-inferiority RCT
In Brief
A clinical study evaluating Intravenous hydration and Subcutaneous hydration for Dehydration. Completed, enrolled 51 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.