Cardiac FunctionPhase 2/3NCT03445221
Preoperative Immunonutrition and Cardiac Patients
A Phase 2/3 study testing IV Immunonutrition and Conventional Diet in people with Cardiac Function, run by Assiut University at 1 site in Egypt.
Trial summary
With the progress of cardiac surgery, the indication of cardiac valve replacement has been extended to include severely ill patients, even those with cardiac cachexia caused by long-standing mitral valve disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiac Function
- What is being tested?
- IV Immunonutrition and Conventional Diet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 31 Mar 2022
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both sex
- Age: 18-60 years.
- Valvular heart disease .
- ASA II,III
- Non-diabetic.
- Elective surgery.
Who cannot join
- Pre-existing renal disease(creatinine3.5mg/dl or dialysis)
- Diabetic.
- Off pump surgery.
- Long CBP time >120 min .
- Previous cardiac surgery.
- Hepatic failure or established cirrhosis.
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implication of Preoperative Immunonutrition Upon Cardiac Patients Undergoing Mitral Valve Replacement Surgery
With the progress of cardiac surgery, the indication of cardiac valve replacement has been extended to include severely ill patients, even those with cardiac cachexia caused by long-standing mitral valve disease. Since patients with advanced cardiac functional disability are prone to fall into a low cardiac output state after valve replacement, Those severely ill, cachectic patients may be susceptible to postoperative acute renal failure. Preoperative malnutrition because of poor oral intake significantly increases the risk of adverse events after surgery and leads to increased length of stay.
Major operation itself possibly cause the dysfunction of the host homeostasis, defense mechanisms and inflammatory response, which would increase the rate of postoperative complications and prolong hospital stay. Recently, many researchers argued that immunonutritional formulas supplemented with biologically active nutrients were more effective than standard nutrition intervention in improving inflammation, promoting the wound healing and shortening the length of hospital stay (LOS) after operation.
Read the detailed description
Eligibility and type of the study: This randomized clinical trial will be conducted at Assiut University Hospital from March 2018 until March 2019 after approval from the Institutional Ethics Committee and after obtaining written informed consents from all cardiac patients undergoing mitral valve replacement surgery.
Randomization and sample size :
Sample size calculation Sample size calculation was carried out using G*Power 3 software. A calculated sample of 88 patients (44 cases and 44 controls) will be needed to detect an effect size of 0.3 reduction in pro-BNP Level, with an error probability of 0.05 and 90% power on a two-tailed test.
Patients:
Patients will be assigned into two equal groups of 44 patients each:
Group 1: patients will take preoperative immunonutrition in the form of intravenous glutamine (Dipeptiven-Fersenius Kabi) 0.4 g/kg/day (once daily) for 5 days before surgery in addition to a conventional diet.
Group 2: patients will continue conventional diet. Conventional median sternotomy will be performed in all patients. Arterial line will be inserted. Anesthesia will be induced with midazolam 0.05mg\kg, propofol 1-1.5mg\kg and fentanyl 2μg\kg. Anesthesia will be maintained with isoflurane, fentanyl infusion1-2μ\kg\hr and Cis-atracurium infusion 2μ\kg\min before cardiopulmonary bypass (CBP) and with propofol and fentanyl on CBP, according the anaesthetist criteria. Anticoagulation will be achieved with heparin 3-4 mg\kg to maintain an activated clotting time over 450s .Reversal of heparin will be with protamine. Cardiopulmonary bypass will be achieved with a roller pump and a membrane oxygenator. After the aortic clamp will be applied, asolution of 1000-1500 cc of hematic cardioplegia will be administrated. Then 400-500 cc of solution will be administrated every 30min until the end of the procedure. Mean arterial pressure should be above 60 mmHg for the duration of CBP.
Data collection:
Cardiac function:
- Preoperative and postoperative echocardiography.
- Inotropic score every 2hours in first 6 hours then every 6 hours for the rest of 48 hours postoperatively.
- Serum proBNP (Brain natruritic peptide) preoperatively and post operative first and forth days.
Kidney function:
- Urine output in the postoperative first and second days.
- Serum urea and creatinine in postoperative first and second days.
- Serum NGAL (Neutrophil gelatinase-associated lipocalin) preoperatively and postoperative first and forth days.
Hemodynamics:
- MAP, HR every 2hours in first 6 hours then every 6 hours for the rest of 48 hours postoperatively.
Hours of mechanical ventilation. Hospital and ICU stay. Any postoperative complications will be recorded and treated.
Sampling:
Venous blood sample will be obtained by direct venipuncture and collected into serum separator tubes. Samples will be centrifuged within 20 minutes from withdrawal and stored for amixture of 12 hours at 2-8 ゜C before the separation of serum. Serum will be stored frozen at -40 ゜C. Pro-BNP serum concentrations will be determined using an automated method.
Statistical analysis :
Data will be performed using a standard SPSS software package version 21 (SPSS Inc., Chicago, Illinois, USA).Descriptive values will be expressed as mean ± SD, number or percentages. The Student t-test will be used for comparison between means of variables and normally distributed data. P will be considered significant if (p≤ 0.05).
Ethical Consideration:
- The randomized clinical trial will be approved by local ethics committee of faculty of medicine, Assiut University, Egypt after obtaining written informed consent from patients.
- There is no risk affecting the patients participating in this study.
- Every patient can leave the study and will receive the same care.
- Any data taken from all patient will be made confidential and available only to persons conducting the study.
- Any patient can stop participation in the study at any time without any loss of service.
- Conditions
- Cardiac Function
- Being tested
- IV Immunonutrition, Conventional Diet
- Keywords
- Immunonutrition, Cardiac Patient, Mitral Valve Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ImmunonutritionDietary supplement
patients will receive preoperative immunonutrition in the form of glutamine) Dipeptiven-Fresenius Kabi) given by intravenous infusion 0.4g/kg/day for 3 days before surgery.
Conventional DietDietary supplement
patients will continue preoperative oral conventional diet.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients will receive preoperative immunonutrition in the form of glutamine) Dipeptiven-Fresenius Kabi) given by intravenous infusion 0.4g/kg/day for 3 days before surgery. Receives: Dietary Supplement: IV Immunonutrition |
| Group II | Active comparator | Patients will continue preoperative oral conventional diet. Receives: Dietary Supplement: Conventional Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Fuction
Serum proBNP (Brain natruritic peptide)
Measured: 4 days
Secondary outcomes (6)
Inotropic score
Dopamine dose (mcg/kg/min) + Dobutamine dose (mcg/kg/min) + 100 x Epinephrine dose (mcg/kg/min) min 20 and max 60 The lower the inotropic score the better cardiac function and lower morbidity
Measured: 4 days
Kidney Function
Serum NGAL (Neutrophil gelatinase-associated lipocalin)
Measured: 4 days
urine output
urine volume per day
Measured: 2 days
Hemodynamics
mean arterial blood pressure
Measured: 2 days
Postoperative Hospital Data
Hospital and ICU stay
Measured: 4 days
Postoperative complications
any postoperative complications
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Aug 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed F. Mostafa, Assiut University
- Investigators
- Khaled M Morsy, MD, Study director, Assistant prof of anesthesia and intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445221
- Sponsor's protocol ID
- Immunonutrition
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2018
- Last updated
- 16 Aug 2022
- 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 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Preoperative Immunonutrition Upon Cardiac Patients Undergoing Mitral Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT03445221
- Acronym / sponsor ID
- Immunonutrition
- Conditions
- Cardiac Function
- Keywords
- Immunonutrition, Cardiac Patient, Mitral Valve Replacement
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 26 Feb 2018 (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.
With the progress of cardiac surgery, the indication of cardiac valve replacement has been extended to include severely ill patients, even those with cardiac cachexia caused by long-standing mitral valve disease. Since patients with advanced cardiac functional disability are prone to fall into a low cardiac output state after valve replacement, Those severely ill, cachectic patients may be susceptible to postoperative acute renal failure. Preoperative malnutrition because of poor oral intake significantly increases the risk of adverse events after surgery and leads to increased length of stay.
Major operation itself possibly cause the dysfunction of the host homeostasis, defense mechanisms and inflammatory response, which would increase the rate of postoperative complications and prolong hospital stay. Recently, many researchers argued that immunonutritional formulas supplemented with biologically active nutrients were more effective than standard nutrition intervention in improving inflammation, promoting the wound healing and shortening the length of hospital stay (LOS) after operation.
Detailed description
Eligibility and type of the study: This randomized clinical trial will be conducted at Assiut University Hospital from March 2018 until March 2019 after approval from the Institutional Ethics Committee and after obtaining written informed consents from all cardiac patients undergoing mitral valve replacement surgery.
Randomization and sample size :
Sample size calculation Sample size calculation was carried out using G*Power 3 software. A calculated sample of 88 patients (44 cases and 44 controls) will be needed to detect an effect size of 0.3 reduction in pro-BNP Level, with an error probability of 0.05 and 90% power on a two-tailed test.
Patients:
Patients will be assigned into two equal groups of 44 patients each:
Group 1: patients will take preoperative immunonutrition in the form of intravenous glutamine (Dipeptiven-Fersenius Kabi) 0.4 g/kg/day (once daily) for 5 days before surgery in addition to a conventional diet.
Group 2: patients will continue conventional diet. Conventional median sternotomy will be performed in all patients. Arterial line will be inserted. Anesthesia will be induced with midazolam 0.05mg\kg, propofol 1-1.5mg\kg and fentanyl 2μg\kg. Anesthesia will be maintained with isoflurane, fentanyl infusion1-2μ\kg\hr and Cis-atracurium infusion 2μ\kg\min before cardiopulmonary bypass (CBP) and with propofol and fentanyl on CBP, according the anaesthetist criteria. Anticoagulation will be achieved with heparin 3-4 mg\kg to maintain an activated clotting time over 450s .Reversal of heparin will be with protamine. Cardiopulmonary bypass will be achieved with a roller pump and a membrane oxygenator. After the aortic clamp will be applied, asolution of 1000-1500 cc of hematic cardioplegia will be administrated. Then 400-500 cc of solution will be administrated every 30min until the end of the procedure. Mean arterial pressure should be above 60 mmHg for the duration of CBP.
Data collection:
Cardiac function:
- Preoperative and postoperative echocardiography.
- Inotropic score every 2hours in first 6 hours then every 6 hours for the rest of 48 hours postoperatively.
- Serum proBNP (Brain natruritic peptide) preoperatively and post operative first and forth days.
Kidney function:
- Urine output in the postoperative first and second days.
- Serum urea and creatinine in postoperative first and second days.
- Serum NGAL (Neutrophil gelatinase-associated lipocalin) preoperatively and postoperative first and forth days.
Hemodynamics:
- MAP, HR every 2hours in first 6 hours then every 6 hours for the rest of 48 hours postoperatively.
Hours of mechanical ventilation. Hospital and ICU stay. Any postoperative complications will be recorded and treated.
Sampling:
Venous blood sample will be obtained by direct venipuncture and collected into serum separator tubes. Samples will be centrifuged within 20 minutes from withdrawal and stored for amixture of 12 hours at 2-8 ゜C before the separation of serum. Serum will be stored frozen at -40 ゜C. Pro-BNP serum concentrations will be determined using an automated method.
Statistical analysis :
Data will be performed using a standard SPSS software package version 21 (SPSS Inc., Chicago, Illinois, USA).Descriptive values will be expressed as mean ± SD, number or percentages. The Student t-test will be used for comparison between means of variables and normally distributed data. P will be considered significant if (p≤ 0.05).
Ethical Consideration:
- The randomized clinical trial will be approved by local ethics committee of faculty of medicine, Assiut University, Egypt after obtaining written informed consent from patients.
- There is no risk affecting the patients participating in this study.
- Every patient can leave the study and will receive the same care.
- Any data taken from all patient will be made confidential and available only to persons conducting the study.
- Any patient can stop participation in the study at any time without any loss of service.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Dietary Supplement: IV ImmunonutritionPatients will receive preoperative immunonutrition in the form of glutamine) Dipeptiven-Fresenius Kabi) given by intravenous infusion 0.4g/kg/day for 3 days before surgery. |
| Group II | Active comparator | Dietary Supplement: Conventional DietPatients will continue preoperative oral conventional diet. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both sex
- Age: 18-60 years.
- Valvular heart disease .
- ASA II,III
- Non-diabetic.
Key exclusion criteria (7 listed)
- Pre-existing renal disease(creatinine3.5mg/dl or dialysis)
- Diabetic.
- Off pump surgery.
- Long CBP time >120 min .
- Previous cardiac surgery.
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 |
|---|---|---|
| IV Immunonutritionpatients will receive preoperative immunonutrition in the form of glutamine) Dipeptiven-Fresenius Kabi) given by intravenous infusion 0.4g/kg/day for 3 days before surgery. | Dietary supplement | Group I |
| Conventional Dietpatients will continue preoperative oral conventional diet. | Dietary supplement | Group II |
Primary outcome
Cardiac Fuction
Time frame: 4 days
Serum proBNP (Brain natruritic peptide)
6 secondary outcomes
Inotropic score
Time frame: 4 days
Kidney Function
Time frame: 4 days
urine output
Time frame: 2 days
Hemodynamics
Time frame: 2 days
Postoperative Hospital Data
Time frame: 4 days
Postoperative complications
Time frame: 4 days
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 16 Aug 2022.
- 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.
Khaled M Morsy, MD study director
Assistant prof of anesthesia and intensive care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IV Immunonutrition and Conventional Diet in people with Cardiac Function, run by Assiut University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 16 Aug 2022. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Cardiac Fuction (time frame: 4 days). 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 16 Aug 2022.