Clinical Trials Logo

Clinical Trial Summary

The aim of this project is to increase knowledge and awareness about nutrition of ICU patients among the staff by evaluating nutrition care on an international level. In order to be able to facilitate bench-marking of ICU's with a national and international standard and actual best practice, we intend to provide a multi-lingual data acquisition tool to determine actual nutrition care in an ICU's.

nutritionDay in Worldwide ICUs is a one day international cross-sectional audit.


Clinical Trial Description

One day international cross-sectional audit in all types of intensive care units. Data are collected with the help of questionnaires. Anonymised data entry into the audit database is done with individual and anonymous center and unit-codes.

There are 4 questionnaires to be completed on nutritionDay.

1. Unit Sheet: asks for nutrition related organisational and structural information on the ward.

2. Patient Medical Information Admission Day: asks for patients status (gender/age/weight/height etc.), date of ICU admission and laboratory parameters on admission day.

3. Patient Medical Information Actual Day: includes questions about treatment (insulin therapy/antibiotic treatment, etc.) and laboratory parameters on actual day.

4. Patient Nutrition: comprises questions about enteral and parenteral nutrition. Number of days of parenteral/enteral feeding, planned amount of calories per day and the patients well being.

Outcome Evaluation: re-assesses the patient's outcome 60 days after nutritionDay (discharged, still in hospital, transferred, death...).

Participation rules:

A user needs to register to nutritionDay as a member to the nutritionDay network. Each may choose a personal user name. Each user needs to provide a valid email address. After responding to a validation email the user is registered with the chosen user name. User details are stored on a system that is not connected to the nutritionDay registry at any time. One user may serve as contact for several units and centers.

A user may order codes for participation for one or several centers and units. Access to the registry is only possible with a center code and unit code. These codes are selected from a list of random numbers.

Audit/registry recruitment plan:

Participation to the registry is voluntary. There is actually no participation fee. All necessary information can be obtained from a dedicated website (www.nutritionday.org). Participation can be promoted via international and national scientific societies, universities, health care organisations or governmental agencies as well as via advertisement at international and national congresses. The target would be intensive care units within hospitals of different sizes and level of care.

Risk and benefit assessment:

The benefit for each patient is that awareness and knowledge about nutrition related factors and treatment options in the treating unit is increased. There is no individual risk since the audit is purely observational.

The benefit for the individual unit is to receive an extensive benchmarking report displaying the unit data in comparison with all units from the same specialty from the previous 3 years immediately after the end of data entry and a validation step. Units or groups of units may request specific reports that can be obtained only after a case by case agreement and financial coverage. All data used as a reference for benchmarking purpose are from units where a minimum of 60% of actually present patients have been recruited and the outcome at day 60 is available in more than 80% of these patients. There is no risk for the unit since anonymity of unit is structurally strictly maintained.

The benefit for the registry up-to-date data enabling benchmarking in pace with medical and care evolution. Moreover the registry data are used for research of the scientific community.

Data security:

On the datasheets the unit and the hospital/center are identified by a numeric code delivered after application to the nutritionDay coordinating center by an automatic system. The only requirement is a valid email address for direct communication with the unit.

Patients are usually identified on the locally used questionnaires by initials and age, but use of initials is not mandatory. Consecutive numbering is also possible. Only the participating unit has to trace patients identifier to be able to collect hospital outcome at day 60 after nutritionDay and to answer automatic requests for data clarification during the data quality feedback.

During data entry into the electronic registry only anonymous codes for center, unit and patients are possible. Thus the data handling centre cannot trace data back to an individual patient. The access to data entry is protected by anonymous center-code and unit-code.

Typically all data are collected via a dedicated website accessed via www.nutritionday.org .

The protected data server is run by the Center for Medical Statistics Informatics and Intelligent Systems (CEMSIS) of the Medical University Vienna. The data server is mirrored and backed up. The data server is protected within the University Firewall against external access.

Data feedback and individual unit report

All participating units are entitled to receive a bench-marking report from the registry. The report generator is started by the participating unit, when data entry has been completed. As a first step each unit receives a data feedback sheet that is based on an electronic data plausibility and missing data analysis. After stating that all data are correctly entered the final report can be generated. This final report offers complete descriptive statistics of the unit data compared to the reference data from the previous 4 years of the corresponding specialty. Only data from units fulfilling a high data quality standard are used for the reference. More than 60% of the patients present in the unit need to participate and 80% of these patients need to have their outcome recorded. Optionally the period used for comparison can be extended until 2007. All descriptive statistics represent prevalent data and are not corrected for cross-sectional sampling to allow direct data control and interpretation.

All downloaded reports of a unit are consecutively numbered and stored for documentation purpose. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04549961
Study type Observational [Patient Registry]
Source Medical University of Vienna
Contact Michael J Hiesmayr, MD, MSc
Phone +43140400
Email michael.hiesmayr@meduniwien.ac.at
Status Recruiting
Phase
Start date January 2007
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT03268902 - Early Life Interventions for Childhood Growth and Development In Tanzania Phase 2/Phase 3
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT04608656 - Livestock for Health Project N/A
Completed NCT06009198 - Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan N/A
Recruiting NCT05417672 - Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
Recruiting NCT05257980 - Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial N/A
Completed NCT03628196 - A Nutrition-Focused QIP in Outpatient Clinics
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Enrolling by invitation NCT04675229 - Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Not yet recruiting NCT06047054 - Incidence Rate and Risk Factors of Malnutrition in ICU
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Not yet recruiting NCT04398836 - Preoperative Nutrition for Crohn's Disease Patients Phase 3
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Not yet recruiting NCT03150927 - Clinical Study of Novel Probiotic Microbial Compositeā„¢ to Treat Undernourished Young Children N/A
Recruiting NCT03408067 - Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients N/A
Recruiting NCT02833740 - Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition N/A
Completed NCT02938247 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake N/A
Completed NCT02938234 - Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake N/A
Completed NCT02800616 - The Healthy Elementary School of the Future N/A