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Completed

NCT Number: NCT01492946

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

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.

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Key information

Conditions

Nutritional Status Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University,

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective surgical intervention
  • Patients must be 18 years or older
  • Ambulation
  • ASA-Score I-IV
  • bioelectrical impedance analysis to determine the phase angle

Exclusion criteria

  • Emergency surgery
  • Pregnancy
  • ASA Score V-VI
  • Amputated limbs
  • Pacemaker and defibrillators
  • Cerebrovascular events
  • Tattoos on the electrode locations

Treatment and study plan

Primary outcomes

  1. Phase-angle

    Time frame: preoperative

Secondary outcomes

  1. body weight

    Time frame: preoperative

  2. body mass index (BMI)

    Time frame: preoperative

  3. preoperative weight loss

    Time frame: 3 month weight loss before operation

  4. hip/waist ratio

    Time frame: preoperative

  5. 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)

  6. 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)

  7. Length of hospital stay

    Time frame: participants will be followed for the duration of hospital stay

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: PreopBIA

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Dec 15, 2011
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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