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Trial record 65 of 226 for:    Recruiting, Not yet recruiting, Available Studies | Aortic stenosis

Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT03341169
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenois Drug: N(2)-L-Alanine L-Glutamine dipeptide Drug: placebo (0.9% NaCl (normal saline)) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Randomized, Double-Blinded, Placebo-Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : September 28, 2019
Estimated Study Completion Date : September 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Experimental: Glutamine
Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
Drug: 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)

Placebo Comparator: Placebo Drug: 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)




Primary Outcome Measures :
  1. degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) [ Time Frame: 1 day before the operation ]
  2. degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) [ Time Frame: 10 minutes after ICU(intensive care unit) entrance, ]
  3. degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) [ Time Frame: 24 hours after surgery ]
  4. degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme) [ Time Frame: 48 hours after surgery ]
  5. Troponin-T(Tn-T) level [ Time Frame: 1 day before the operation ]
  6. Troponin-T(Tn-T) level [ Time Frame: 24 hours after surgery ]

Secondary Outcome Measures :
  1. IL-6 [ Time Frame: a day before surgery ]
  2. IL-6 [ Time Frame: 10 minutes after ICU(intensive care unit) entrance ]
  3. Free fatty acid [ Time Frame: a day before surgery ]
  4. Free fatty acid [ Time Frame: 10 minutes after ICU(intensive care unit) entrance ]
  5. CRP [ Time Frame: a day before surgery ]
  6. CRP [ Time Frame: 24 hours after surgery ]
  7. cardiovascular index [ Time Frame: 10 minutes after ICU(intensive care unit) entrance ]
  8. cardiovascular index [ Time Frame: 12 hours after surgery ]
  9. cardiovascular index [ Time Frame: 24 hours after surgery ]
  10. occurrence of sternal infections [ Time Frame: Within 30 days postoperatively ]
  11. mortality [ Time Frame: During hospitalization regardless of length of stay or within 30 days of surgery if discharged ]
  12. occurrence of cardiovascular complications [ Time Frame: up to 1 year ]
    *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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341169


Contacts
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Contact: Jong Wook Song, MD 82-2-2227-3971 SJW72331@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jong Wook Song, MD    82-2-2227-3971    SJW72331@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03341169     History of Changes
Other Study ID Numbers: 4-2017-0774
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction