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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

December 14, 2011
July 5, 2012
May 2010
November 2010   (final data collection date for primary outcome measure)
Phase-angle [ Time Frame: preoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01492946 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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)
Not Provided
Not Provided
 
Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome
Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome (PreopBIA)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Elective surgical patients

Nutritional Status
Not Provided
Elective surgical patients
Elective surgical patients in the Charité University Berlin Campus Charité Mitte
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
387
July 2012
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01492946
PreopBIA
No
Claudia Spies, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Study Director: Claudia Spies, MD Prof. Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University, Berlin, Germany
Charite University, Berlin, Germany
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP