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

April 29, 2008 updated by: Soroka University Medical Center

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

Methods: Patients in the homecare setting who meet the criteria for parentral infusion and suffer: pain, vomit/nausea and/or agitation will be recruited for the study.

A double blind crossover methodology will be used. Each patient will serve as both intervention and control, and both patient and medical staff will be blinded to the medication route administration. A research nurse will administer the medications. Crossover will take place 48 hours thereafter. A research assistant will conduct evaluation of symptoms and side effects for a period of 4 days. A sample size of 27 patients will be included in the study (calculated for a significance level of 95% and power of 80%).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel, 653
        • Ben-Gurion University of the Negev Sial Research Center for Family Medicine and Primary Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Patients and caregivers that refuse to participate.
  2. Every occasion when the infusion period will be less than 48 hours.
  3. 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.
  4. Patients that will need other medications subcutaneously that are not included in the study during their study treatment period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
level of symptoms control

Secondary Outcome Measures

Outcome Measure
complications and side effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Collaborators

Ben-Gurion University of the Negev

Investigators

  • Principal Investigator: Sasson Menachem, MD, Ben-Gurion University of the Negev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (ESTIMATE)

May 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2008

Last Update Submitted That Met QC Criteria

April 29, 2008

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SOR316302CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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