MalnutritionMalnutritionNCT01243528
Observational Study at the Influence of Malnutrition on Infections
An observational study of Malnutrition, run by Marion Mertl-Roetzer at 1 site in Germany.
Trial summary
The purpose of this trial is to determine whether nutritional status has an impact on nosocomial infections. Study population are patients undergoing early neurological rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Laboratory values
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Dec 2010
- 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: Patients in neurological rehabilitation facility
Who may be able to join
- Patients in early neurological rehabilitation
- informed consent given
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Non-interventional Observational Study at the Influence of Malnutrition on Nosocomial Infections in Patients During Early Neurological Rehabilitation
The purpose of this trial is to determine whether nutritional status has an impact on nosocomial infections. Study population are patients undergoing early neurological rehabilitation.
- Conditions
- Malnutrition
- Being tested
- Laboratory values
- Keywords
- Malnutrition, Infection, Neurological
- Medical subject headings
- Malnutrition, Infections, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory valuesOther
Also called Vitamin D, Creatinine, Urea nitrogen, Albumin
Laboratory values which represent nutritional status
| Study group | Role | What they receive |
|---|---|---|
| Patients in neurological rehabilitation | Patients suffering from a neurological disease Receives: Other: Laboratory values |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Nutritional status is represented by Prognostic Inflammatory and Nutritional Index Score (PINI) and bioimpedanz-anlaysis-measurement (BIA)
Measured: 8 weeks
Secondary outcomes (1)
Nosocomial infections
Survey whether the patient has infections during the observation period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marion Mertl-Roetzer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marion Mertl-Roetzer, Schoen Clinic Bad Aibling
- Investigators
- Marion Mertl-Rötzer, Dr. med., Principal investigator, Schoen Clinic Bad Aibling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243528
- Sponsor's protocol ID
- PINI01
- Acronym
- Malnutrition
- Status last verified
- Dec 2014
- First submitted
- 17 Nov 2010
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional Observational Study at the Influence of Malnutrition on Nosocomial Infections in Patients During Early Neurological Rehabilitation
- ClinicalTrials.gov ID
- NCT01243528
- Acronym / sponsor ID
- Malnutrition / PINI01
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Infection, Neurological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Marion Mertl-RoetzerUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Nov 2010 (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 purpose of this trial is to determine whether nutritional status has an impact on nosocomial infections. Study population are patients undergoing early neurological rehabilitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in neurological rehabilitation | – | Other: Laboratory valuesPatients suffering from a neurological disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in neurological rehabilitation facility
Key inclusion criteria (2 listed)
- Patients in early neurological rehabilitation
- informed consent given
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Laboratory valuesAlso: Vitamin D, Creatinine, Urea nitrogen, AlbuminLaboratory values which represent nutritional status | Other | Patients in neurological rehabilitation |
Primary outcome
Nutritional status
Time frame: 8 weeks
Nutritional status is represented by Prognostic Inflammatory and Nutritional Index Score (PINI) and bioimpedanz-anlaysis-measurement (BIA)
1 secondary outcome
Nosocomial infections
Time frame: 8 weeks
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 15 Dec 2014.
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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.
Marion Mertl-Rötzer, Dr. med. principal investigator
Schoen Clinic Bad Aibling
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 Marion Mertl-Roetzer 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 2 inclusion and 1 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 15 Dec 2014. 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?
Nutritional status (time frame: 8 weeks). 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 15 Dec 2014.