NCT00425529

Brief Summary

The primary objective of this clinical trial is to test the tolerance and practicality of the new device Module AOX. The secondary objective is to determine the changes in oxidative, antioxidative status, plasma free amino acids, and various immune parameters in critically ill patients receiving the enteral nutrition with and without using Module AOX.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
Last Updated

January 23, 2007

Status Verified

January 1, 2007

First QC Date

January 22, 2007

Last Update Submit

January 22, 2007

Conditions

Gastrointestinal DiseasesNutrition

Outcome Measures

Primary Outcomes (2)

  • Tolerance: stool outcome (frequency, consistency), diarrhea, faltulence, abdominal pain, amount of feeding according to goal, changes of amount fed, discontinuation of feeding

  • Practicality: time for connecting the device to the pouch, time needing for mixing content of device with the content of the enteral feding pouch, clotting of theadministration set, product flow,leakage, clarity of instructions of usage

Secondary Outcomes (1)

  • vitamin C, Vitamin E. beta-caroteen, GSH/GSSG, cysteine/cystine, GPx, isoprostane, TAS, Zn, Se, plasma free amino acids, HLADR, TNF soluble receptors (55/75), LBP, BPI, IL-1 IR II, leptin, soluble leptin receptor, IL-6, IL-8, and microciological safety

Interventions

Module AOX (attached to Sondalis ISO)DEVICE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who will undergo major surgery of esophagus, stomach or pancreas
  • patients who will be eligible for jejunostomy feeding
  • age \>18 and \<75 y
  • BMI \< 35
  • having obtained his/her or his/her legal representative's informed consent

You may not qualify if:

  • patients with a history of main cardiovascular or kidney disease
  • weigth loss \>10% during the last 6 months
  • patients who have received corticosteroids, or investigational drugs, in the last 6 weekd prior to surgery
  • patients with HIV infection
  • patients who are participating in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU Medical Center

Amsterdam, North Holland, 1007 MB, Netherlands

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Paul AM van Leeuwen, MD, PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 23, 2007

Study Start

February 1, 2002

Study Completion

May 1, 2003

Last Updated

January 23, 2007

Record last verified: 2007-01

Locations

NL(1)