Malnutrition; ProteinNCT05118165
Influence of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty
A study testing Dietary supplement with protein in people with Malnutrition; Protein and Frail Elderly Syndrome, run by Lithuanian University of Health Sciences.
Trial summary
The aim of the study is to determine whether the optimisation of the preoperative nutritional status affects the course of the perioperative period in patients with frailty. Subjects: Patients 65 and over years of age with frailty or risk of it, with suboptimal nutritional status who are prescribed to elective cardiac… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Malnutrition; Protein, Frail Elderly Syndrome
- What is being tested?
- Dietary supplement with protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 12 Nov 2021to 11 Jul 2023
- Phase
- Interventional
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients 65 years of age and older.
- Patients for whom cardiac surgery will be performed on a scheduled basis.
- Patients able to move without the help of others except for an aid: a stick, a walker.
- Patients who speak and understand Lithuanian perfectly.
- Patients who have read the informed consent form and confirmed their consent to participate in the study in writing.
Who cannot join
- Patiens younger than 65 years.
- No written consent of a person to participate in a biomedical research has been obtained;
- Patients with a history of mental illness or central nervous system disorders that interfere with the perception and proper assessment of their health and the meaning and content of the questionnaire / tasks.
- Patients with amputated lower extremities.
- Patients with hepatic insufficiency, one or more of viral hepatitis.
- It is not possible to perform a qualitative physical examination for other reasons (hearing, vision, etc.)
- Allergy to B vitamins.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Optimization of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty
The aim of the study is to determine whether the optimisation of the preoperative nutritional status affects the course of the perioperative period in patients with frailty.
Subjects: Patients 65 and over years of age with frailty or risk of it, with suboptimal nutritional status who are prescribed to elective cardiac surgery .
Read more
Research methods: Edmonton Crispness Scale, a Mini Nutritional Assessment (MNA-SF) test will be used to select subjects. Body composition will be examined by bioelectrical impedance analysis (BIA) to determine the degree of phase angle. Changes in laboratory blood tests will be recorded and evaluated The subjects randomly will be divided into control and study groups.
The diet of the patients in the study group will be optimised by protein supplements before elective heart surgery.
The benefits of optimising nutritional status will be evaluated comparing laboratory blood tests, changes in organ function, adverse outcomes, the need for vasoactive drugs, artificial lung ventilation time and length of hospitalisation between the groups.
- Conditions
- Malnutrition; Protein, Frail Elderly Syndrome
- Being tested
- Dietary supplement with protein
- Keywords
- preoperative malnutrition, frailty, cardiac surgery
- Medical subject headings
- Kwashiorkor, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement with proteinDietary supplement
Will be included protein supplements in the preoperative diet.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| intervention group | Experimental | Not described Receives: Dietary Supplement: Dietary supplement with protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative outcomes
The rate of postoperative complications
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start12 Nov 2021 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion11 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition; ProteinStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrida Drigotiene, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118165
- Sponsor's protocol ID
- SAI
- Other IDs
- SUT_SAI
- Status last verified
- Nov 2021
- First submitted
- 14 Sep 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Optimization of Preoperative Nutritional Status on Perioperative Period in Cardiac Surgery in Patients With Frailty
- ClinicalTrials.gov ID
- NCT05118165
- Acronym / sponsor ID
- SAI
- Conditions
- Malnutrition; Protein, Frail Elderly Syndrome
- Keywords
- preoperative malnutrition, frailty, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 12 Nov 2021 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 11 Jul 2023 (estimated)
- First posted
- 11 Nov 2021 (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.
The aim of the study is to determine whether the optimisation of the preoperative nutritional status affects the course of the perioperative period in patients with frailty.
Subjects: Patients 65 and over years of age with frailty or risk of it, with suboptimal nutritional status who are prescribed to elective cardiac surgery .
Research methods: Edmonton Crispness Scale, a Mini Nutritional Assessment (MNA-SF) test will be used to select subjects. Body composition will be examined by bioelectrical impedance analysis (BIA) to determine the degree of phase angle. Changes in laboratory blood tests will be recorded and evaluated The subjects randomly will be divided into control and study groups.
The diet of the patients in the study group will be optimised by protein supplements before elective heart surgery.
The benefits of optimising nutritional status will be evaluated comparing laboratory blood tests, changes in organ function, adverse outcomes, the need for vasoactive drugs, artificial lung ventilation time and length of hospitalisation between the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| intervention group | Experimental | Dietary Supplement: Dietary supplement with protein |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients 65 years of age and older.
- Patients for whom cardiac surgery will be performed on a scheduled basis.
- Patients able to move without the help of others except for an aid: a stick, a walker.
- Patients who speak and understand Lithuanian perfectly.
- Patients who have read the informed consent form and confirmed their consent to participate in the study in writing.
Key exclusion criteria (7 listed)
- Patiens younger than 65 years.
- No written consent of a person to participate in a biomedical research has been obtained;
- Patients with a history of mental illness or central nervous system disorders that interfere with the perception and proper assessment of their health and the meaning and content of the questionnaire / tasks.
- Patients with amputated lower extremities.
- Patients with hepatic insufficiency, one or more of viral hepatitis.
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 |
|---|---|---|
| Dietary supplement with proteinWill be included protein supplements in the preoperative diet. | Dietary supplement | intervention group |
Primary outcome
Postoperative outcomes
Time frame: up to 2 weeks
The rate of postoperative complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement with protein in people with Malnutrition; Protein and Frail Elderly Syndrome, run by Lithuanian University of Health Sciences.
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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingrida Drigotienė, m.d. (+37065222724, ingrida.drigotiene@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative outcomes (time frame: up to 2 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 11 Nov 2021.