OPTIMIZATION OF NUTRITIONAL MANAGEMENT OF PATIENTS WAITING FOR LUNG TRANSPLANT INTO Strasbourg University Hospitals (nONsTOP)

December 14, 2017 updated by: University Hospital, Strasbourg, France

Undernutrition is the result of energy and protein deficiency and / or catabolic. These phenomena are observed daily in patients awaiting lung transplantation.

After lung transplantation that undernutrition is growing (on average 11% weight loss after the first observations in the continuing care of the University Hospital of Strasbourg). In other words the non-malnourished patients become. Hence the importance to reach every patient awaiting transplant, mainly to patients already malnourished before surgery.

Several studies have shown that early nutritional support has a direct effect on reducing comorbidities and the average length of stay. In the course of care of these patients it is necessary to intensify the dietary management to give them the best chance for early rehabilitation.

The main objective of the study is to evaluate the impact of the use of the SFNEP's nutritional care decision-making tree (Société Francophone Nutrition Clinique et Métabolisme) on the implementation of enteral nutrition by gastrostomy tube in patients awaiting for lung transplantation.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

62

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

  • France
      • Strasbourg, France, 67091
        • Service de pneumologie - Nouvel Hôpital Civil

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

transplant patients between January 1, 2012 and December 31, 2015 aged over 16 years, with a BMI <25 at the time of pre-transplant assessment

Description

Inclusion criteria:

transplant patients between January 1, 2012 and December 31, 2015 aged over 16 years, with a BMI <25 at the time of pre-transplant assessment and that not oppose the use of his data.

Exclusion criteria:

  • Cardiopulmonary Transplant Patients
  • refusal to participate in the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the proportion undernourished patients by using the SFNEP's nutritional care decision-making tree
Time Frame: befor pulmonary transplantation, up to 1 year
befor pulmonary transplantation, up to 1 year

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Sophie BOURA, Dietician, University Hospital, Strasbourg, France

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 (Actual)

August 17, 2016

Primary Completion (Actual)

August 22, 2016

Study Completion (Actual)

February 16, 2017

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

December 15, 2017

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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