Nutritional StatusPreopBIANCT01492946
Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome
An observational study of Nutritional Status, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Status
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective surgical patients
Who may be able to join
- Elective surgical intervention
- Patients must be 18 years or older
- Ambulation
- ASA-Score I-IV
- bioelectrical impedance analysis to determine the phase angle
Who cannot join
- Emergency surgery
- Pregnancy
- ASA Score V-VI
- Amputated limbs
- Pacemaker and defibrillators
- Cerebrovascular events
- Tattoos on the electrode locations
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University,
Berlin, State of Berlin, 10117
About this study
Official title: 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.
- Conditions
- Nutritional Status
- Keywords
- Malnutrition, Post-operative outcome, Phase angle, MUST, Clavien Dindo classification, Bioelectrical impedance analysis
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elective surgical patients | Elective surgical patients in the Charité University Berlin Campus Charité Mitte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase-angle
Measured: preoperative
Secondary outcomes (7)
body weight
Measured: preoperative
body mass index (BMI)
Measured: preoperative
preoperative weight loss
Measured: 3 month weight loss before operation
hip/waist ratio
Measured: preoperative
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)
Measured: preoperative
postoperative complications
The Clavien-Dindo Classification of Surgical Complications (Dindo D., Demartines N., Clavien P.A.; Ann Surg. 2004; 244: 931-937)
Measured: postoperative
Length of hospital stay
Measured: participants will be followed for the duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startMay 2010
- Primary completionNov 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD Prof., Study director, Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492946
- Sponsor's protocol ID
- PreopBIA
- Acronym
- PreopBIA
- Status last verified
- Jan 2017
- First submitted
- 14 Dec 2011
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome (PreopBIA)
- ClinicalTrials.gov ID
- NCT01492946
- Acronym / sponsor ID
- PreopBIA / PreopBIA
- Conditions
- Nutritional Status
- Keywords
- Malnutrition, Post-operative outcome, Phase angle, MUST, Clavien Dindo classification, Bioelectrical impedance analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective surgical patients | – | –Elective surgical patients in the Charité University Berlin Campus Charité Mitte |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective surgical patients
Key inclusion criteria (5 listed)
- Elective surgical intervention
- Patients must be 18 years or older
- Ambulation
- ASA-Score I-IV
- bioelectrical impedance analysis to determine the phase angle
Key exclusion criteria (7 listed)
- Emergency surgery
- Pregnancy
- ASA Score V-VI
- Amputated limbs
- Pacemaker and defibrillators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phase-angle
Time frame: preoperative
7 secondary outcomes
body weight
Time frame: preoperative
body mass index (BMI)
Time frame: preoperative
preoperative weight loss
Time frame: 3 month weight loss before operation
hip/waist ratio
Time frame: preoperative
Malnutrition Universal Screening Tool (MUST)
Time frame: preoperative
postoperative complications
Time frame: postoperative
Length of hospital stay
Time frame: participants will be followed for the duration of hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD Prof. study director
Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase-angle (time frame: preoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.