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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01492946
First received: December 14, 2011
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  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)

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

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

Primary Outcome Measures:
  • Phase-angle [ Time Frame: preoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body weight [ Time Frame: preoperative ] [ Designated as safety issue: No ]
  • body mass index (BMI) [ Time Frame: preoperative ] [ Designated as safety issue: No ]
  • preoperative weight loss [ Time Frame: 3 month weight loss before operation ] [ Designated as safety issue: No ]
  • hip/waist ratio [ Time Frame: preoperative ] [ Designated as safety issue: No ]
  • Malnutrition Universal Screening Tool (MUST) [ Time Frame: preoperative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 387
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Claudia Spies, study director, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01492946     History of Changes
Other Study ID Numbers: PreopBIA
Study First Received: December 14, 2011
Last Updated: July 5, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013