Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients
January 30, 2019 updated by: Dr. Felix Aigner, Charite University, Berlin, Germany
Assessing Nutritional Status and Nutrient Supply in Hospitalised Patients Undergoing Major Abdominal Surgery of the Gastrointestinal Tract
Prospective single arm, single center observational study to assess the nutritional status and the nutrient supply during hospitalization for elective gastrointestinal surgery.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
128
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
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Berlin, Germany, 13353
- Charité - Universitätsmedizin Berlin
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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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Elective surgical patients
Description
Inclusion Criteria:
- patients undergoing elective surgery of the upper or lower gastrointestinal tract
- mental and verbal ability to understand, read and write in German language
- written informed consent for study participation
Exclusion Criteria:
- age <18 years
- inadequate ability to be compliant with the study protocol or to complete documentation for the Food frequency questionnaires
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 |
Measure Description |
Time Frame |
|---|---|---|
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Change in nutritional status
Time Frame: 24 hours pre-surgery and 7 days after surgery
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Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7
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24 hours pre-surgery and 7 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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length of hospital stay
Time Frame: 14 days
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14 days
|
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Energy intake
Time Frame: 1 day before surgery, the day of surgery and up to 7 days after surgery
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Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day
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1 day before surgery, the day of surgery and up to 7 days after surgery
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Change in plasma amino acid levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
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Blood sample analysis
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24 hours pre-surgery up to 7 days after surgery
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Change in beta-hydroxybutyrate levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
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Blood sample analysis
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24 hours pre-surgery up to 7 days after surgery
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Change in free fatty acid levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
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Blood sample analysis
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24 hours pre-surgery up to 7 days after surgery
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Change in triacylglycerides levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
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Blood sample analysis
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24 hours pre-surgery up to 7 days after surgery
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Change in low density lipoprotein levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
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Blood sample analysis
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24 hours pre-surgery up to 7 days after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 1, 2017
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
December 7, 2018
First Submitted That Met QC Criteria
December 23, 2018
First Posted (Actual)
December 26, 2018
Study Record Updates
Last Update Posted (Actual)
January 31, 2019
Last Update Submitted That Met QC Criteria
January 30, 2019
Last Verified
January 1, 2019
More Information
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.