Validity Study of Glutamine to Improve Cardiac Function in Cardiac Surgery
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Purpose
In view of the lack of large-scale clinical study and potent evidence-based medicine, the investigators designed a randomized, double-blind, placebo-controlled study to ascertain whether preoperative intravenous administration with glutamine can improve the postoperative cardiac function and prognosis of adult patients undergoing cardiac surgery. The investigators want to detect the concentration of blood Gln, levels of myocardial protein O-GlcNAc modification and HSP70 expression, changes in sensitive indicators of myocardial injury, systemic inflammatory reaction and oxidative stress levels, and to examine the correlation between these changes and Clinical manifestations. The ultimate goal of the study is to explore a new way for clinical myocardial protection.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatic Heart Disease Coronary Heart Disease |
Drug: Glutamine Drug: Amino acid Drug: Ringer's solution |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Intravenous Supplementation of Glutamine Preoperatively for Cardiac Function and Recovery Improvement in Adult Accepting Cardiosurgery: A Randomized, Double-Blinded, Placebo-Controlled Trial |
- perioperative changes of Cardiac Index (CI) [ Time Frame: postanescesia before surgery, 2, 20 hours after cardiopulmonary bypass (CPB) ] [ Designated as safety issue: No ]For each patient,a Swan-Ganz catheter will be inserted after anesthesia induction.CI and other values of hemodynamics will be measured.
- Troponin I(cTnI) [ Time Frame: postanescesia before surgery, 6, 20 hours after CPB ] [ Designated as safety issue: No ]CTnI is a sensitive indicator of myocardial damage.
- Brain Natriuretic Peptide (BNP) [ Time Frame: postanescesia before surgery, 6, 20 hours after CPB ] [ Designated as safety issue: No ]BNP is a sensitive indicator of cardiac dysfunction.
- Systemic inflammation [ Time Frame: postanescesia before surgery, 2, 20 hours after CPB ] [ Designated as safety issue: No ]Blood levels of Interleukin-6（IL-6）、Tumor Necrosis Factor（TNF-a） and Malondialdehyde (MDA) will be measured.
- Blood concentration of Gln [ Time Frame: postanescesia before surgery, 2, 20 hours after CPB ] [ Designated as safety issue: No ]We want to be sure that the blood concentration of Gln was increased compared to the control group after intravenous glutamine supplementation.
- Heart issue HSP-70 [ Time Frame: 20 minutes after CPB ] [ Designated as safety issue: No ]A mass of heart tissue (a part of right auricle of heart,weigh about 50mg) will be cut 20 minutes after CPB for the measurements.
- Heart issue O-GlcNAc [ Time Frame: 20 minutes after CPB ] [ Designated as safety issue: No ]The same mass of heart tissue described above will be used for the measurements.
- Recovery index [ Time Frame: Date of surgery until date of hospital discharge (an expected average of 2 weeks) ] [ Designated as safety issue: Yes ]Recovery index include duration of mechanical ventilation、duration of ICU stay、duration of hospital stay、adverse event and mortality.
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Glutamine
20% N(2)-L-alanyl-L-glutamine 0.4g/kg(2ml/kg) mixed with compound amino acid (10ml/kg)(volume ratio=1:5).Intravenous injection twice (24 hours、1 hour before operation).
|
Drug: Glutamine
20% N(2)-L-alanyl-L-glutamine 0.4g/kg(2ml/kg) mixed with compound amino acid (10ml/kg).Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h
Other Name: Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)
|
|
Placebo Comparator: Amino acid
Compound amino acid 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation).
|
Drug: Amino acid
Compound amino acid 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation).Injection rate = 6ml/kg/h.
Other Names:
|
|
Placebo Comparator: Ringer's solution
Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation).
|
Drug: Ringer's solution
Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h.
|
Detailed Description:
Cardiosurgery is mostly done under cardiopulmonary bypass. However, the cardiopulmonary bypass and the later recovery of spontaneous circulation, a cardiac ischemia / reperfusion process, may cause myocardial damage and affect cardiac function as well as prognosis.
Glutamine, an amino acid abundant in the human body, plays an important role in the regulation of metabolism and immune cells and the protection of organs. Relative lack of glutamine is reported during stress or serious illness. Animal studies have confirmed that pretreatment with glutamine has a protective effect on the heart, liver, kidney and other organs post ischemia / reperfusion injury. It is also established that glutamine exerts myocardial protection mainly by activating hexosamine biosynthetic pathway, increasing intracellular O-GlcNAc protein modification and expression of heat shock protein 70 (HSP70), starting the protective reaction in the body, improving the function of myocardial cells, and inhibiting the release of inflammatory cytokines and oxidative stress levels. Besides, clinical studies have shown that at the perioperative stage glutamine has a protective effect on cardiac function of the patients treated with pump coronary artery bypass surgery.
The purpose of this study is to ascertain whether preoperative intravenous administration with glutamine (as compared with control group) can improve the postoperative cardiac function and prognosis of adult patients undergoing cardiac surgery and reduce inflammatory response and oxidative stress levels of the body. The correlation between Clinical manifestations and expression of myocardium O-GlcNAc and HSP70 will also be investigated.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients with coronary artery disease or rheumatic heart disease accepted cardiosurgery under cardiopulmonary bypass
Exclusion Criteria:
- ejection fraction(EF)<50%
- Preoperative support with intra-aortic balloon pump(IABP)
- Hepatosis
- Renal dysfunction
- Myocardial infarction attack within 3 months
- Emergency operation
Contacts and Locations| Contact: Yuejiang Liu, Master | +86-025-83262527 | yuejiangliu@126.com |
| Contact: Liang Jing, PhD | +86-025-83262522 | jinglg@gmail.com |
| China, Jiangsu | |
| Zhongda Hospital Southeast University | Recruiting |
| Nanjing, Jiangsu, China, 210009 | |
| Contact: Yuejiang Liu, Master +86-025-83262527 yuejiangliu@126.com | |
| Contact: Liang Jing, PhD +86-025-83262522 jinglg@gmail.com | |
More Information
No publications provided
| Responsible Party: | Yuejiang Liu, Associate Professor, Southeast University, China |
| ClinicalTrials.gov Identifier: | NCT01794884 History of Changes |
| Other Study ID Numbers: | glncardio001 |
| Study First Received: | February 4, 2013 |
| Last Updated: | February 16, 2013 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Southeast University, China:
|
Glutamine Cardiosurgery Cardiopulmonary bypass Cardiac function Recovery |
Additional relevant MeSH terms:
|
Rheumatic Fever Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Rheumatic Diseases Rheumatic Heart Disease Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Musculoskeletal Diseases Connective Tissue Diseases Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 19, 2013