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

  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin

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
Change in nutritional status
Time Frame: 24 hours pre-surgery and 7 days after surgery
Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7
24 hours pre-surgery and 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: 14 days
14 days
Energy intake
Time Frame: 1 day before surgery, the day of surgery and up to 7 days after surgery
Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day
1 day before surgery, the day of surgery and up to 7 days after surgery
Change in plasma amino acid levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
Blood sample analysis
24 hours pre-surgery up to 7 days after surgery
Change in beta-hydroxybutyrate levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
Blood sample analysis
24 hours pre-surgery up to 7 days after surgery
Change in free fatty acid levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
Blood sample analysis
24 hours pre-surgery up to 7 days after surgery
Change in triacylglycerides levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
Blood sample analysis
24 hours pre-surgery up to 7 days after surgery
Change in low density lipoprotein levels
Time Frame: 24 hours pre-surgery up to 7 days after surgery
Blood sample analysis
24 hours pre-surgery up to 7 days after surgery

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

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

Terms related to this study

Keywords

Other Study ID Numbers

  • EA2/094/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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