NCT02807311

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 17, 2016

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2017

Completed
Last Updated

December 15, 2017

Status Verified

May 1, 2016

Enrollment Period

5 days

First QC Date

June 15, 2016

Last Update Submit

December 14, 2017

Conditions

Keywords

MalnutritionUndernutritionlung transplantationartificial nutritionnutritional supplementsenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Assessment of the proportion undernourished patients by using the SFNEP's nutritional care decision-making tree

    befor pulmonary transplantation, up to 1 year

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Cardiopulmonary Transplant Patients
  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de pneumologie - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Sophie BOURA, Dietician

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 21, 2016

Study Start

August 17, 2016

Primary Completion

August 22, 2016

Study Completion

February 16, 2017

Last Updated

December 15, 2017

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations