Clinical trial NCT03341169: Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
Official title: Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenois
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Double-Blinded, Placebo-Controlled Trial
Primary purpose: PREVENTION

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
timeFrame: 1 day before the operation
measure: degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
timeFrame: 10 minutes after ICU(intensive care unit) entrance,
measure: degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
timeFrame: 24 hours after surgery
measure: degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
timeFrame: 48 hours after surgery
measure: Troponin-T(Tn-T) level
timeFrame: 1 day before the operation
measure: Troponin-T(Tn-T) level
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: IL-6
timeFrame: a day before surgery
measure: IL-6
timeFrame: 10 minutes after ICU(intensive care unit) entrance
measure: Free fatty acid
timeFrame: a day before surgery
measure: Free fatty acid
timeFrame: 10 minutes after ICU(intensive care unit) entrance
measure: CRP
timeFrame: a day before surgery
measure: CRP
timeFrame: 24 hours after surgery
measure: cardiovascular index
timeFrame: 10 minutes after ICU(intensive care unit) entrance
measure: cardiovascular index
timeFrame: 12 hours after surgery
measure: cardiovascular index
timeFrame: 24 hours after surgery
measure: occurrence of sternal infections
timeFrame: Within 30 days postoperatively
measure: mortality
timeFrame: During hospitalization regardless of length of stay or within 30 days of surgery if discharged
measure: occurrence of cardiovascular complications
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References: