Quality Project Malnutrition Intensive Care | NCT02911181

Studies
Quality Project Malnutrition Intensive Care

NCT02911181

Sponsor

Frisius Medisch Centrum

Status

Completed

Last Update Posted

Sep 22, 2016Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Malnutrition

Interventions

BIVA measurement

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Jun 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Mar 7, 2016

First Submission Date that Met QC Criteria

Sep 20, 2016

First Posted Date

Sep 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2016

Last Update Posted Date

Sep 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Observational study to investigate nutrition state in all admitted patients in ICU. Measurement by BIVA and SNAQ score.

Detailed Description

Malnutrition is a great problem in healthcare, its related to mortality, infections and length of stay. Observational study to investigate nutrition state in all admitted patients in ICU. Measurement by BIVA and SNAQ score.

All patients were asked for their nutrition state by SNAQ and the BIVA measurement is done by a trained doctor.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Name	Type	Description	Arm Group Labels	Other Names
BIVA measurement	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
malnutrition	percentage of patients with malnutrition at admission on the ICU	day 1 in Intensive Care

Secondary Outcomes

Measure	Description	Time Frame
malnutrition in elective and acute patients	Is there a difference in malnutrition between elective patients and acute patients	day 1 in Intensive Care

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

admission ICU

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients admitted in the ICU between feb 2016 and may 2016

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matty Koopmans, MSc	Intensive Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Centre Leeuwarden		Leeuwarden			Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29460815	Derived	Buter H, Veenstra JA, Koopmans M, Boerma CE. Phase angle is related to outcome after ICU admission; an observational study. Clin Nutr ESPEN. 2018 Feb;23:61-66. doi: 10.1016/j.clnesp.2017.12.008. Epub 2017 Dec 20.

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases