A clinical trial exploring the administration of intravenous antibiotics and fluids via intravenous pole and pump versus portable CADD pump to improve mobility in patients diagnosed with cancer (The Active Trial)

A Randomised Controlled Trial exploring the administration of intravenous antibiotics and fluids via intravenous pole and pump versus portable CADD pump to improve mobility in patients diagnosed with cancer (The Active Trial)

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001531101

Acronym

The Active Trial

Enrollment

Registered

2019-11-06

Start date

2023-07-04

Completion date

2024-05-07

Last updated

2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to compare the currently used IV pole and pump to a smaller, portable IV pump, called a CADD pump, for the administration of IV antibiotics and IV fluids. You may be eligible for this study if you are aged 18 years or over and are a cancer inpatient who has been prescribed intravenous antibiotics or fluids. Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will use the CADD pump to receive their IV antibiotics/fluids, and the other group will use the existing IV pole and pump system. All participants will wear a step-counter, called an accelerometer, on their wrist. Patients will be asked to consent to the study by a research nurse and will be required to answer some brief questionnaires during their involvement in the study. It is hoped this research will show that the CADD pump helps inpatients to be more mobile in hospital, and that this will lead to improved patient outcomes and reduced hospital-acquired complications.

Interventions

The intervention group will receive intravenous antibiotics (IVABs)/intravenous (IV) fluids via a Computerised Ambulatory Delivery Device (CADD) pump. The CADD pump is a small, battery-powered infusion pump that promotes mobility by delivering IV medication/fluids without the need for an IV pole. It is connected to the patient's Central Venous Access Device (CVAD) and is stored in a small, carry bag and travels with the patient as they mobilise and perform activities of daily living. Participants will receive the prescribed IVAB/fluids as a continuous, 24 hour infusion for a maximum treatment period of seven (7) days. CADD pump adherence will be documented via the CADD pump observations chart in the comments/variances section, to be completed by nursing staff every 4 hours. This document will be reviewed by the research nurse daily.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Medical oncology and haematology inpatients with a CVAD, 2. Patients 18 years of age and over, 3. Patients with a Glasgow Coma Scale (GCS) of 15, 4. Patients prescribed an IVAB and IV fluids suitable for continuous infusion over 24-hours

Exclusion criteria

1. Patients that are immobile, bed-bound, require spinal cord precautions, or have oxygen requirements when mobilising. 2. Patients that are isolated due to contact, droplet or airborne precautions (i.e. have tested positive for MRSA, VRE, C-Diff, Influenza A & B, Parainfluenza, RSV, Adenovirus or Norovirus).

Outcome results