Aortic Valve StenoisNCT03341169
Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
A study testing N(2)-L-Alanine L-Glutamine dipeptide in people with Aortic Valve Stenois, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Aortic Valve Stenois
- What is being tested?
- N(2)-L-Alanine L-Glutamine dipeptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2018to 28 Sep 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with between 20 and 80 years scheduled for aortic valve replacement alone or combined surgery including aortic valve replacement due to severe aortic valve stenosis
Who cannot join
- Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
- patients who are considering surgery for coronary artery disease or who have a stenosis> 70%
- hemodynamically unstable patients undergoing emergency surgery or patients with intra-aortic balloon pump insertion
- patients unable to make their own decisions, illiterate, foreigners
- epilepsy
- severe metabolic acidosis
Show all 12Show fewer
- pulmonary edema
- history of myocardial infarction
- elevation of total bilirubin or AST / ALT
- Patients higher than normal, weighing more than 80 kg
- with evidence of infection
- pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
Jong Wook Song, MD, 82-2-2227-3971, SJW72331@yuhs.ac
About this study
The purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the degree of myocardial damage(with CK-MB and Troponin T) and myocardial protection (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction, and clinical manifestation.
- Conditions
- Aortic Valve Stenois
- Being tested
- N(2)-L-Alanine L-Glutamine dipeptide, placebo (0.9% NaCl (normal saline))
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N(2)-L-Alanine L-Glutamine dipeptideDrug
:Intravenous infusion of N (2) -L-alanyl-L-glutamine(mixed with normal saline, ratio 1:1) at the dose of 0.25g/kg(body weight) for 8 hours before induction of anesthesia(rate=2.5*weight/8 ml/h) and administration another 0.25g/kg(body weight) of N (2) -L-alanyl-L-glutamine(mixed with 8.5% amino acid solution, ratio 1:5) into the central vein for 10 hours after induction of anesthesia(rate=0.75*weight ml/h)
placebo (0.9% NaCl (normal saline))Drug
Intravenous infusion of 0.9% NaCl for 8 hours before induction of anesthesia(rate=2.5*weight/8 ml/h) and administration 0.9% NaCl into the central vein for 10 hours after induction of anesthesia(rate=0.75*weight ml/h)
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Experimental | Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia) Receives: Drug: N(2)-L-Alanine L-Glutamine dipeptide |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo (0.9% NaCl (normal saline)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Measured: 1 day before the operation
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Measured: 10 minutes after ICU(intensive care unit) entrance,
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Measured: 24 hours after surgery
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Measured: 48 hours after surgery
Troponin-T(Tn-T) level
Measured: 1 day before the operation
Troponin-T(Tn-T) level
Measured: 24 hours after surgery
Secondary outcomes (12)
IL-6
Measured: a day before surgery
IL-6
Measured: 10 minutes after ICU(intensive care unit) entrance
Free fatty acid
Measured: a day before surgery
Free fatty acid
Measured: 10 minutes after ICU(intensive care unit) entrance
CRP
Measured: a day before surgery
CRP
Measured: 24 hours after surgery
cardiovascular index
Measured: 10 minutes after ICU(intensive care unit) entrance
cardiovascular index
Measured: 12 hours after surgery
cardiovascular index
Measured: 24 hours after surgery
occurrence of sternal infections
Measured: Within 30 days postoperatively
mortality
Measured: During hospitalization regardless of length of stay or within 30 days of surgery if discharged
occurrence of cardiovascular complications
*cardiovascular (myocardial infarction, heart failure, arrhythmia), cerebral infarction, renal failure: During the hospitalization for surgery, which includes the entire postoperative period up to discharge, even if over 30 days
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start20 Mar 2018
- Primary completion28 Sep 2019 (estimated)
- Study completion28 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenoisStudies of the same condition, open and under way.
- More trials run by Yonsei 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double-Blinded, Placebo-Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341169
- Sponsor's protocol ID
- 4-2017-0774
- Status last verified
- Jan 2019
- First submitted
- 23 Oct 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03341169
- Acronym / sponsor ID
- 4-2017-0774
- Conditions
- Aortic Valve Stenois
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 28 Sep 2019 (estimated)
- Study completion
- 28 Sep 2019 (estimated)
- First posted
- 14 Nov 2017 (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 purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the degree of myocardial damage(with CK-MB and Troponin T) and myocardial protection (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction, and clinical manifestation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double-Blinded, Placebo-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Experimental | Drug: N(2)-L-Alanine L-Glutamine dipeptideIntravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia) |
| Placebo | Placebo comparator | Drug: placebo (0.9% NaCl (normal saline)) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with between 20 and 80 years scheduled for aortic valve replacement alone or combined surgery including aortic valve replacement due to severe aortic valve stenosis
Key exclusion criteria (12 listed)
- Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
- patients who are considering surgery for coronary artery disease or who have a stenosis> 70%
- hemodynamically unstable patients undergoing emergency surgery or patients with intra-aortic balloon pump insertion
- patients unable to make their own decisions, illiterate, foreigners
- epilepsy
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 |
|---|---|---|
| N(2)-L-Alanine L-Glutamine dipeptide:Intravenous infusion of N (2) -L-alanyl-L-glutamine(mixed with normal saline, ratio 1:1) at the dose of 0.25g/kg(body weight) for 8 hours before induction of anesthesia(rate=2.5*weight/8 ml/h) and administration another 0.25g/kg(body weight) of N (2) -L-alanyl-L-glutamine(mixed with 8.5% amino acid solution, ratio 1:5) into the central vein for 10 hours after induction of anesthesia(rate=0.75*weight ml/h) | Drug | Glutamine |
| placebo (0.9% NaCl (normal saline))Intravenous infusion of 0.9% NaCl for 8 hours before induction of anesthesia(rate=2.5*weight/8 ml/h) and administration 0.9% NaCl into the central vein for 10 hours after induction of anesthesia(rate=0.75*weight ml/h) | Drug | Placebo |
Primary outcome
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Time frame: 1 day before the operation
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Time frame: 10 minutes after ICU(intensive care unit) entrance,
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Time frame: 24 hours after surgery
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
Time frame: 48 hours after surgery
Troponin-T(Tn-T) level
Time frame: 1 day before the operation
Troponin-T(Tn-T) level
Time frame: 24 hours after surgery
12 secondary outcomes
IL-6
Time frame: a day before surgery
IL-6
Time frame: 10 minutes after ICU(intensive care unit) entrance
Free fatty acid
Time frame: a day before surgery
Free fatty acid
Time frame: 10 minutes after ICU(intensive care unit) entrance
CRP
Time frame: a day before surgery
CRP
Time frame: 24 hours after surgery
cardiovascular index
Time frame: 10 minutes after ICU(intensive care unit) entrance
cardiovascular index
Time frame: 12 hours after surgery
cardiovascular index
Time frame: 24 hours after surgery
occurrence of sternal infections
Time frame: Within 30 days postoperatively
mortality
Time frame: During hospitalization regardless of length of stay or within 30 days of surgery if discharged
occurrence of cardiovascular complications
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N(2)-L-Alanine L-Glutamine dipeptide in people with Aortic Valve Stenois, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 12 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 10 Jan 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 South Korea. 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.
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 Jong Wook Song, MD (82-2-2227-3971, SJW72331@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) (time frame: 1 day before the operation). The study lists 6 primary outcomes in all. 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 10 Jan 2019.