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
  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:


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 April 21, 2014