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

This study has been completed.
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00320866
First received: May 1, 2006
Last updated: April 29, 2008
Last verified: May 2006
  Purpose

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%).


Condition Intervention
Home Infusion Therapy
Infusion Pumps
Device: syringe driver

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • level of symptoms control

Secondary Outcome Measures:
  • complications and side effects

Estimated Enrollment: 27
Study Start Date: February 2002
Study Completion Date: December 2007
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320866

Locations
Israel
Ben-Gurion University of the Negev Sial Research Center for Family Medicine and Primary Care
Beer Sheva, Israel, 653
Sponsors and Collaborators
Soroka University Medical Center
Ben-Gurion University of the Negev
Investigators
Principal Investigator: Sasson Menachem, MD Ben-Gurion University of the Negev
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00320866     History of Changes
Other Study ID Numbers: SOR316302CTIL
Study First Received: May 1, 2006
Last Updated: April 29, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Hypodermoclysis
Evaluation of Symptoms

ClinicalTrials.gov processed this record on October 01, 2014