Heart DiseasesPhase 3NCT01312870
Study of Postoperative Nutritional Support in Cardiac Surgery.
A Phase 3 study testing Ensure, Abbott Nutrition and standard hospital diet in people with Heart Diseases, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in Russia.
Trial summary
The purpose of this study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Ensure, Abbott Nutrition and standard hospital diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesRussia
- Study dates
- Mar 2011to Mar 2015
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Absolute lymphocyte count < 1500
- Albumin <35 g/L
- Body mass index<21 kg/m2
- "B" class of nutritional status according to Subjective Global Assessment
Who cannot join
- Hepatitis B, C
- Total circulatory arrest
- Absence of informed consent signed
- Chronic liver diseases
- Gastric resection in patient's history
- Physical limitations of normal feeding
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk
State Research Institute of CIrculation Pathology
Novosibirsk
About this study
Official title: Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.
The purpose of this study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition .
- Conditions
- Heart Diseases
- Being tested
- Ensure, Abbott Nutrition, standard hospital diet
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure, Abbott NutritionDietary supplement
Enteral feeding Ensure, Abbott Nutrition 400 ml per day for seven postoperative days
standard hospital dietOther
standard hospital diet
| Study group | Role | What they receive |
|---|---|---|
| postoperative nutritional supplements | Experimental | postoperative nutritional supplements in addition to standard hospital diet Receives: Dietary Supplement: Ensure, Abbott Nutrition |
| standard hospital diet | Placebo comparator | patients receiving standard hospital diet Receives: Other: standard hospital diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 month
Secondary outcomes (5)
Postoperative complications
Cardiac arrhythmia, infectious complications.
Measured: 1 month
Total lymphocyte count
Measured: before operation, 7, 14, 21 postoperative days
Serum albumin
Measured: Before operation, 7, 14, 21 postoperaitve days
Serum prealbumin
Measured: Before operation, 7, 14, 21 postoperaitve days
Retinol-binding protein
Measured: Before operation, 7, 14, 21 postoperaitve days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312870
- Sponsor's protocol ID
- PNSICP-71421
- Status last verified
- Mar 2015
- First submitted
- 2 Mar 2011
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT01312870
- Acronym / sponsor ID
- PNSICP-71421
- Conditions
- Heart Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Mar 2011 (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 study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative nutritional supplements | Experimental | Dietary Supplement: Ensure, Abbott Nutritionpostoperative nutritional supplements in addition to standard hospital diet |
| standard hospital diet | Placebo comparator | Other: standard hospital dietpatients receiving standard hospital diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Absolute lymphocyte count < 1500
- Albumin <35 g/L
- Body mass index<21 kg/m2
- "B" class of nutritional status according to Subjective Global Assessment
Key exclusion criteria (6 listed)
- Hepatitis B, C
- Total circulatory arrest
- Absence of informed consent signed
- Chronic liver diseases
- Gastric resection in patient's history
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 |
|---|---|---|
| Ensure, Abbott NutritionEnteral feeding Ensure, Abbott Nutrition 400 ml per day for seven postoperative days | Dietary supplement | postoperative nutritional supplements |
| standard hospital dietstandard hospital diet | Other | standard hospital diet |
Primary outcome
Mortality
Time frame: 1 month
5 secondary outcomes
Postoperative complications
Time frame: 1 month
Total lymphocyte count
Time frame: before operation, 7, 14, 21 postoperative days
Serum albumin
Time frame: Before operation, 7, 14, 21 postoperaitve days
Serum prealbumin
Time frame: Before operation, 7, 14, 21 postoperaitve days
Retinol-binding protein
Time frame: Before operation, 7, 14, 21 postoperaitve days
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Related trials for Heart Diseases
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ensure, Abbott Nutrition and standard hospital diet in people with Heart Diseases, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in Russia.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Mortality (time frame: 1 month). 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 24 Mar 2015.