MalnutritionNCT04088825
Validation of the CONUT Software Tool for Screening Clinical Malnutrition in the University Hospital La Paz
An observational study of Malnutrition, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Nutrition Department of University Hospital La Paz decided to implement some method of screening in our centre which allowed us to detect as many patients with malnutrition risk as possible. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- CONUT screening system
- How many people
- 233 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2012to 31 Dec 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: Cross-sectional study in which the nutritional status of patients will be assessed in the first 72 hours of entry.
Who may be able to join
- Patients of both sexes
- Patients older than 15 years
- Patients admitted to the General Hospital or Traumatology area
- Patients who have signed the informed consent to participate in the study
- Patients who do not meet any exclusion criteria.
Who cannot join
- Pregnant women.
- Patients whose physical and / or psychic capacity prevents them from providing all the data collected by the evaluated methods or who do not have a caregiver.
- Non-collaborating patients in data collection
- Patients in whom a hospital stay of less than 48 hours is expected.
- Patients who at the time of performing the analyzes are in the ICU and OER
Trial locations and contacts
1 site in 1 country.
About this study
Nutrition Department of University Hospital La Paz decided to implement some method of screening in our centre which allowed us to detect as many patients with malnutrition risk as possible. Due to the large size of our centre, with about 1,500 beds and the few human resources in our unit, we chose to use the CONUT system (Nutritional Control), a 100% automatic method based on analytical parameters, very easy to use, low cost and whose validity is confirmed, characteristics that fulfilled our needs. The implementation of this nutritional screening method has led to a change in the ìnutritionafi culture of our centre respect to DRM in most of our professionals: doctors and nurses and even in the management team, so all of them understand the importance of the process and know about the available tools and knowledge to indicate an adequate and early nutritional support.
- Conditions
- Malnutrition
- Being tested
- CONUT screening system
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONUT screening systemOther
CONUT has been working from june of 2010 and it has detected risk of malnutrition in 32% of the evaluated patients. The method collects information from databases of Admission Service (affiliation, age, date) and Laboratory (albumin, cholesterol, total lymphocytes) and generates, in the report of analytical results, "alert" information about each patient's nutritional risk and also nutritional recommendations based on the risk identified.
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect as many patients with malnutrition risk as possible
The method collects information from databases of Admission Service (affiliation, age, date) and Laboratory (albumin, cholesterol, total lymphocytes) and generates, in the report of analytical results, "alert" information about each patient's nutritional risk and also nutritional recommendations based on the risk identified. Prior to its implantation several evaluations were performed in order to allow us to better know the extra workload, as it was the main factor that could limit our ability to assume that screening method and also many training activities for doctors and hospital health professionals who were increasingly assuming responsibilities in the nutritional treatment of their patients.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start15 Jul 2012
- Primary completion15 Sep 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, Msc, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088825
- Sponsor's protocol ID
- HULP PI-2340
- Status last verified
- Aug 2019
- First submitted
- 12 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the CONUT Software Tool for Screening Clinical Malnutrition in the University Hospital La Paz
- ClinicalTrials.gov ID
- NCT04088825
- Acronym / sponsor ID
- HULP PI-2340
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 15 Jul 2012 (actual)
- Primary completion
- 15 Sep 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 13 Sep 2019 (actual)
- 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.
Nutrition Department of University Hospital La Paz decided to implement some method of screening in our centre which allowed us to detect as many patients with malnutrition risk as possible. Due to the large size of our centre, with about 1,500 beds and the few human resources in our unit, we chose to use the CONUT system (Nutritional Control), a 100% automatic method based on analytical parameters, very easy to use, low cost and whose validity is confirmed, characteristics that fulfilled our needs. The implementation of this nutritional screening method has led to a change in the ìnutritionafi culture of our centre respect to DRM in most of our professionals: doctors and nurses and even in the management team, so all of them understand the importance of the process and know about the available tools and knowledge to indicate an adequate and early nutritional support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cross-sectional study in which the nutritional status of patients will be assessed in the first 72 hours of entry.
Key inclusion criteria (5 listed)
- Patients of both sexes
- Patients older than 15 years
- Patients admitted to the General Hospital or Traumatology area
- Patients who have signed the informed consent to participate in the study
- Patients who do not meet any exclusion criteria.
Key exclusion criteria (5 listed)
- Pregnant women.
- Patients whose physical and / or psychic capacity prevents them from providing all the data collected by the evaluated methods or who do not have a caregiver.
- Non-collaborating patients in data collection
- Patients in whom a hospital stay of less than 48 hours is expected.
- Patients who at the time of performing the analyzes are in the ICU and OER
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONUT screening systemCONUT has been working from june of 2010 and it has detected risk of malnutrition in 32% of the evaluated patients. The method collects information from databases of Admission Service (affiliation, age, date) and Laboratory (albumin, cholesterol, total lymphocytes) and generates, in the report of analytical results, "alert" information about each patient's nutritional risk and also nutritional recommendations based on the risk identified. | Other | – |
Primary outcome
To detect as many patients with malnutrition risk as possible
Time frame: Three months
The method collects information from databases of Admission Service (affiliation, age, date) and Laboratory (albumin, cholesterol, total lymphocytes) and generates, in the report of analytical results, "alert" information about each patient's nutritional risk and also nutritional recommendations based on the risk identified. Prior to its implantation several evaluations were performed in order to allow us to better know the extra workload, as it was the main factor that could limit our ability to assume that screening method and also many training activities for doctors and hospital health professionals who were increasingly assuming responsibilities in the nutritional treatment of their patients.
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 13 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Carmen Gómez Candela, Msc principal investigator
Hospital Universitario La Paz
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 Malnutrition, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 5 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 13 Sep 2019. 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 Spain. 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?
To detect as many patients with malnutrition risk as possible (time frame: Three months). 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 13 Sep 2019.