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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02807311
Other study ID # 6369
Secondary ID
Status Completed
Phase N/A
First received June 15, 2016
Last updated December 14, 2017
Start date August 17, 2016
Est. completion date February 16, 2017

Study information

Verified date May 2016
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date February 16, 2017
Est. primary completion date August 22, 2016
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de pneumologie - Nouvel Hôpital Civil Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the proportion undernourished patients by using the SFNEP's nutritional care decision-making tree befor pulmonary transplantation, up to 1 year
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