Evaluation of Symptoms, Complications and Side Effects of Adding Medications Continuously To Subcutaneous Infusion (Hypodermoclysis) In Home Care Hospice Patients

NCT00320866 | Completed

• 1 other identifier: SOR316302CTIL
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Terminal patients are often unable to swallow and need medications to control symptoms. In these cases medications are administered continuously and subcutaneously by a syringe driver. A syringe driver is an expensive and sophisticated equipment to operate. Hypodermoclysis is a useful and easy alternative used in the homecare setting for hydration. Objectives:

1. 1.To assess the level of symptoms control by the administration of morphine, metoclopramide and midazolam by hypodermoclysis versus by a syringe driver.
2. 2.To assess the complications and side effects of infusing these medications continuously by hypodermoclysis versus by a syringe driver.

Conditions

Home Infusion Therapy; Infusion Pumps

Keywords

Hypodermoclysis; Evaluation of Symptoms

Outcome Measures

Primary Outcomes (1)

• level of symptoms control

Secondary Outcomes (1)

• complications and side effects

Interventions

syringe driver DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in the home care unit that need medication/s continuously subcutaneously with symptoms level of 6 or higher on a visual analogue scale (VAS) for that symptom.

You may not qualify if:

• Patients and caregivers that refuse to participate.
• Every occasion when the infusion period will be less than 48 hours.
• Every occasion when the patient and/or main care giver are not able to provide reliable information by the judgment of the medical staff person or research worker.
• Patients that will need other medications subcutaneously that are not included in the study during their study treatment period.

Sponsors & Collaborators

• Soroka University Medical Center: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

Ben-Gurion University of the Negev Sial Research Center for Family Medicine and Primary Care

Beersheba, 653, Israel

Location

Study Officials

• Sasson Menachem, MD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: February 1, 2002
• Study Completion: December 1, 2007
• Last Updated: April 30, 2008

Record last verified: 2006-05

Locations

IL (1)