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Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome (PreopBIA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01492946
First Posted: December 15, 2011
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
  Purpose
The aim of this retrospective observational study is to determine the impact of preoperative nutritional status on postoperative outcome. Elective surgical patients were screened with Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for body composition. Outcome parameters were collected by patient chart review.

Condition
Nutritional Status

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome (PreopBIA)

Further study details as provided by Claudia Spies, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Phase-angle [ Time Frame: preoperative ]

Secondary Outcome Measures:
  • body weight [ Time Frame: preoperative ]
  • body mass index (BMI) [ Time Frame: preoperative ]
  • preoperative weight loss [ Time Frame: 3 month weight loss before operation ]
  • hip/waist ratio [ Time Frame: preoperative ]
  • Malnutrition Universal Screening Tool (MUST) [ Time Frame: preoperative ]
    The MUST is recommended by ESPEN as the preferred screening tool for patients in the community (Kondrup J et al., Clinical Nutrition 2003; 22: 415-421)

  • postoperative complications [ Time Frame: postoperative ]
    The Clavien-Dindo Classification of Surgical Complications (Dindo D., Demartines N., Clavien P.A.; Ann Surg. 2004; 244: 931-937)

  • Length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay ]

Enrollment: 400
Study Start Date: May 2010
Study Completion Date: July 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Elective surgical patients
Elective surgical patients in the Charité University Berlin Campus Charité Mitte

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elective surgical patients
Criteria

Inclusion Criteria:

  1. Elective surgical intervention
  2. Patients must be 18 years or older
  3. Ambulation
  4. ASA-Score I-IV
  5. bioelectrical impedance analysis to determine the phase angle

Exclusion Criteria:

  1. Emergency surgery
  2. Pregnancy
  3. ASA Score V-VI
  4. Amputated limbs
  5. Pacemaker and defibrillators
  6. Cerebrovascular events
  7. Tattoos on the electrode locations
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492946


Locations
Germany
Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University,
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Claudia Spies, MD Prof. Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University, Berlin, Germany
  More Information

Responsible Party: Claudia Spies, study director, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01492946     History of Changes
Other Study ID Numbers: PreopBIA
First Submitted: December 14, 2011
First Posted: December 15, 2011
Last Update Posted: January 23, 2017
Last Verified: January 2017

Keywords provided by Claudia Spies, Charite University, Berlin, Germany:
Malnutrition
Post-operative outcome
Phase angle
MUST
Clavien Dindo classification
Bioelectrical impedance analysis