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

Nutritional Status Clinical Trial

— PreopBIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492946
• Other study ID #: PreopBIA
• Status: Completed
• Phase: N/A
• First received: December 14, 2011
• Last updated: January 20, 2017
• Start date: May 2010
• Est. completion date: July 2012

Study information

• Verified date: January 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Status

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University,	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase-angle		preoperative
Secondary	body weight		preoperative
Secondary	body mass index (BMI)		preoperative
Secondary	preoperative weight loss		3 month weight loss before operation
Secondary	hip/waist ratio		preoperative
Secondary	Malnutrition Universal Screening Tool (MUST)	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)	preoperative
Secondary	postoperative complications	The Clavien-Dindo Classification of Surgical Complications (Dindo D., Demartines N., Clavien P.A.; Ann Surg. 2004; 244: 931-937)	postoperative
Secondary	Length of hospital stay		participants will be followed for the duration of hospital stay