Oral Glutamine in Cardiopulmonary Bypass

NCT02491931 | Completed DMC

• 1 other identifier: Glutamine-2015
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Glutamine (GLN) is the most abundant free amino acid in the body. It modulates immune cell function and is an important energy substrate for most cells (especially for enterocytes and lymphocytes) in critical patients. GLN levels significantly decreased during sepsis/critical illness leading to an increase in infectious complications, organ failure and mortality. Moreover, in cases of ischemia/reperfusion injury in the myocardium, GLN increases the levels of Adenosine triphosphate (ATP)/Adenosine diphosphate (ADP) ratio and prevents intracellular lactate accumulation. Recently, the perioperative effect of intravenous and oral GLN treatment been associated in lowering levels of cardiac injury markers such as Troponin-I (TROP-I) and the number of postoperative complications in patients who underwent Cardiopulmonary Bypass (CPB). The aim of the study was to analyze the oral dose of preoperative oral GLN treatment in patients who underwent CPB with extracorporeal circulation in Mexican patients.

Conditions

Ischemic Heart Disease

Keywords

Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Dietary Supplements; Glutamine; TROPONIN I; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (12)

• Troponin-I

  Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  1 hour before surgery.

• Creatine Kinase

  Blood sample (10 ml) was taken from patient and analyzed to obtain Creatine Kinase levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  1 hour before surgery

• Creatine Kinase - Mb

  Blood sample (10 ml) was taken from patient and analyzed to obtain Creatine Kinase-Mb levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  1 hour before surgery

• Troponin-I

  Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  one hour after surgery.

• Creatine Kinase

  Blood sample (10 ml) was taken from patient and analyzed to obtain Creatine Kinase-Mb levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  one hour after surgery.

• Creatine Kinase - Mb

  Blood sample (10 ml) was taken from patient and analyzed to obtain Creatine Kinase-Mb levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  one hour after surgery.

• Troponin-I

  Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  12 hours after surgery

• Creatine Kinase

  Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  12 hours after surgery

• Creatine Kinase - Mb

  Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  12 hours after surgery

• Troponin-I

  Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  24 hours after surgery

• Creatine Kinase

  Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  24 hours after surgery

• Creatine Kinase - Mb

  Blood sample (10 ml) was taken from patient and analyzed to obtain Troponin-I levels were captured using Meso Scale technology (Meso Scale Discovery, Gaithersburg, MD).

  24 hours after surgery

Secondary Outcomes (5)

• Postoperative Stroke

  15 days after surgery.

• Length of stay in UCI.

  15 days after surgery.

• Mortality

  15 days after surgery.

• Postoperative Infections

  15 days after surgery.

• Postoperative vasopressor therapy

  15 days after surgery.

Study Arms (2)

GLN group

ACTIVE COMPARATOR

All patients in the GLN group received an oral GLN supplement. The total GLN dose given to patients was standardized to 0.5 g/kg/day during 3 days prior to CPB, and one final dose of 0.25 g/kg/day of GLN/maltodextrin in the morning of surgery 4 hours prior to initiation of anesthesia.

Dietary Supplement: Supplement/placebo intake

CONT group

PLACEBO COMPARATOR

All patients in the GLN group received an oral maltodextrin supplement, similar in shape and texture as GLN supplement. The total placebo given to patients was standardized to 0.5 g/kg/day during 3 days prior to CPB, and one final dose of 0.25 g/kg/day of maltodextrin in the morning of surgery 4 hours prior to initiation of anesthesia.

Dietary Supplement: Supplement/placebo intake

Interventions

Supplement/placebo intake DIETARY_SUPPLEMENT

Patients will receive either GLN or placebo prior to cardiovascular surgery under extracorporeal circulation, during 3 days and one final dose 4 hours prior to anesthesia.

CONT group; GLN group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of Ischemic heart disease in whom cardiac revascularization (cardiac by pass) was going to be performed.
• Written informed consent from each patient.

You may not qualify if:

• Preexisting kidney disease
• Liver dysfunction
• Drug or alcohol abuse Positivity to human immunodeficiency virus (HIV)
• Hepatitis B / C
• Allergies against components of GLN.
• Patients with an ongoing ischemia, defined by persistent elevation of TROP-I and CPK-MB levels.
• If any dietetic supplement of GLN was taken simultaneously.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Related Publications (18)

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  PMID: 20563423 RESULT

• Wernerman J. Glutamine supplementation. Ann Intensive Care. 2011 Jul 18;1(1):25. doi: 10.1186/2110-5820-1-25.

  PMID: 21906372 RESULT

• Singleton KD, Beckey VE, Wischmeyer PE. GLUTAMINE PREVENTS ACTIVATION OF NF-kappaB AND STRESS KINASE PATHWAYS, ATTENUATES INFLAMMATORY CYTOKINE RELEASE, AND PREVENTS ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) FOLLOWING SEPSIS. Shock. 2005 Dec;24(6):583-9. doi: 10.1097/01.shk.0000185795.96964.71.

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• Wischmeyer PE. Glutamine: role in critical illness and ongoing clinical trials. Curr Opin Gastroenterol. 2008 Mar;24(2):190-7. doi: 10.1097/MOG.0b013e3282f4db94.

  PMID: 18301270 RESULT

• Coeffier M, Dechelotte P. The role of glutamine in intensive care unit patients: mechanisms of action and clinical outcome. Nutr Rev. 2005 Feb;63(2):65-9. doi: 10.1111/j.1753-4887.2005.tb00123.x.

  PMID: 15762090 RESULT

• Oudemans-van Straaten HM, Bosman RJ, Treskes M, van der Spoel HJ, Zandstra DF. Plasma glutamine depletion and patient outcome in acute ICU admissions. Intensive Care Med. 2001 Jan;27(1):84-90. doi: 10.1007/s001340000703.

  PMID: 11280678 RESULT

• Jimenez Jimenez FJ, Cervera Montes M, Blesa Malpica AL; Metabolism and Nutrition Working Group of the Spanish Society of Intensive Care Medicine and Coronary units. Guidelines for specialized nutritional and metabolic support in the critically-ill patient: update. Consensus SEMICYUC-SENPE: cardiac patient. Nutr Hosp. 2011 Nov;26 Suppl 2:76-80. doi: 10.1590/S0212-16112011000800017.

  PMID: 22411526 RESULT

• Fuentes-Orozco C, Anaya-Prado R, Gonzalez-Ojeda A, Arenas-Marquez H, Cabrera-Pivaral C, Cervantes-Guevara G, Barrera-Zepeda LM. L-alanyl-L-glutamine-supplemented parenteral nutrition improves infectious morbidity in secondary peritonitis. Clin Nutr. 2004 Feb;23(1):13-21. doi: 10.1016/s0261-5614(03)00055-4.

  PMID: 14757388 RESULT

• Sufit A, Weitzel LB, Hamiel C, Queensland K, Dauber I, Rooyackers O, Wischmeyer PE. Pharmacologically dosed oral glutamine reduces myocardial injury in patients undergoing cardiac surgery: a randomized pilot feasibility trial. JPEN J Parenter Enteral Nutr. 2012 Sep;36(5):556-61. doi: 10.1177/0148607112448823. Epub 2012 May 23.

  PMID: 22623413 RESULT

• Lomivorotov VV, Efremov SM, Shmirev VA, Ponomarev DN, Lomivorotov VN, Karaskov AM. Glutamine is cardioprotective in patients with ischemic heart disease following cardiopulmonary bypass. Heart Surg Forum. 2011 Dec;14(6):E384-8. doi: 10.1532/HSF98.20111074.

  PMID: 22167767 RESULT

• Wischmeyer PE, Jayakar D, Williams U, Singleton KD, Riehm J, Bacha EA, Jeevanandam V, Christians U, Serkova N. Single dose of glutamine enhances myocardial tissue metabolism, glutathione content, and improves myocardial function after ischemia-reperfusion injury. JPEN J Parenter Enteral Nutr. 2003 Nov-Dec;27(6):396-403. doi: 10.1177/0148607103027006396.

  PMID: 14621120 RESULT

• Groening P, Huang Z, La Gamma EF, Levy RJ. Glutamine restores myocardial cytochrome C oxidase activity and improves cardiac function during experimental sepsis. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):249-54. doi: 10.1177/0148607110383040.

  PMID: 21378254 RESULT

• Villar J, Edelson JD, Post M, Mullen JB, Slutsky AS. Induction of heat stress proteins is associated with decreased mortality in an animal model of acute lung injury. Am Rev Respir Dis. 1993 Jan;147(1):177-81. doi: 10.1164/ajrccm/147.1.177.

  PMID: 8420414 RESULT

• Ziegler TR, Ogden LG, Singleton KD, Luo M, Fernandez-Estivariz C, Griffith DP, Galloway JR, Wischmeyer PE. Parenteral glutamine increases serum heat shock protein 70 in critically ill patients. Intensive Care Med. 2005 Aug;31(8):1079-86. doi: 10.1007/s00134-005-2690-5. Epub 2005 Jun 23.

  PMID: 15973519 RESULT

• Khogali SE, Harper AA, Lyall JA, Rennie MJ. Effects of L-glutamine on post-ischaemic cardiac function: protection and rescue. J Mol Cell Cardiol. 1998 Apr;30(4):819-27. doi: 10.1006/jmcc.1998.0647.

  PMID: 9602431 RESULT

• Twerenbold R, Reichlin T, Reiter M, Muller C. High-sensitive cardiac troponin: friend or foe? Swiss Med Wkly. 2011 May 10;141:w13202. doi: 10.4414/smw.2011.13202. eCollection 2011.

  PMID: 21557113 RESULT

• McGuinness J, Neilan TG, Cummins R, Sharkasi A, Bouchier-Hayes D, Redmond JM. Intravenous glutamine enhances COX-2 activity giving cardioprotection. J Surg Res. 2009 Mar;152(1):140-7. doi: 10.1016/j.jss.2008.03.045. Epub 2008 Apr 28.

  PMID: 18708191 RESULT

• Khogali SE, Pringle SD, Weryk BV, Rennie MJ. Is glutamine beneficial in ischemic heart disease? Nutrition. 2002 Feb;18(2):123-6. doi: 10.1016/s0899-9007(01)00768-7.

  PMID: 11844641 RESULT

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• González-Ojeda Alejandro, MD. PhD. F.A.C.S.

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

• Chávez-Tostado Mariana, M.Sc. R. Nutr.

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., Ph.D., F.A.C.S.

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: July 8, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 3, 2023

Record last verified: 2023-09