Glutamine to Improve Outcomes in Cardiac Surgery

NCT01704430 | Completed

• 1 other identifier: MAZ_CVICU_001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Patients undergoing heart surgery with a heart-lung machine (termed cardiopulmonary bypass) are at an increased risk of having abnormal "inflammation" in their body after surgery. Such inflammation can contribute to slower recovery from surgery, an increased risk of infection, an increased risk of damage to organs other than the heart, and a more complicated course. Prior research has suggested that using an oral protein supplement made of glutamine (an essential amino acid normally found in your body) can reduce the risk of inflammation, infection and the length of stay in hospital in patients who have suffered major trauma or a burn injury. The investigators believe reducing such inflammation after heart surgery may help promote recovery and reduce the risk of adverse events and complications. The purpose of this preliminary study is to see if oral glutamine supplementation after heart surgery is practical, and contributes to a reduction in inflammation. The oral glutamine proposed in this study is based on what has been previously studied and what is considered safe.

Conditions

Nosocomial Infection

Keywords

Cardiac surgery; Cardiac bypass; Intensive Care; Nosocomial infection; Glutamine; Randomized trial

Outcome Measures

Primary Outcomes (1)

• Proportion of Eligible Patients Providing Consent to Participate

  Assess the FEASIBILITY of the protocol to (i) achieve \>75% consent rate in eligible patients

  Date of surgery until date of hospital discharge, an expected average of 2 weeks

Secondary Outcomes (9)

• Acute Kidney Injury

  Date of surgery until date of hospital discharge, an expected average of 2 weeks

• Duration of mechanical ventilation

  Date of surgery until date of hospital discharge, an expected average of 2 weeks

• Duration of vasoactive support

  Date of surgery until date of hospital discharge, an expected average of 2 weeks

• Blood transfusion

  Date of surgery until date of hospital discharge, an expected average of 2 weeks

• Organ Dysfunction Score

  Date of surgery until date of hospital discharge, an expected average of 2 weeks

Other Outcomes (3)

• Mortality

  From the Date of Surgery until Date of Death or 90-days, whichever occurs first

• Duration of ICU stay

  Date of surgery until date of hospital discharge, an expected average of 2 weeks

• Duration of hospital stay

  Date of surgery until date of hospital discharge, an expected average of 2 weeks

Study Arms (2)

Glutamine

EXPERIMENTAL

Oral/enteral glutamine 0.5 g/kg satisfactory body weight per day (divided doses every 8 hours) starting 6 hours post-operatively

Dietary Supplement: Glutamine

Maltodextrin

PLACEBO COMPARATOR

Oral/enteral maltodextrin 0.5 g/kg satisfactory body weight per day (divided doses every 8 hours) starting 6 hours post-operatively

Dietary Supplement: Maltodextrin

Interventions

Glutamine DIETARY_SUPPLEMENT

Enteric L-Glutamine

Also known as: L-Glutamine

Glutamine

Maltodextrin DIETARY_SUPPLEMENT

Enteric Maltodextrin

Maltodextrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent (obtained pre-operatively)
• Adult - aged 18 years or older;
• Planned cardiovascular surgery with cardiopulmonary bypass;
• Increased risk for post-operative morbidity, defined by a pre-operative European System for Operative Cardiac Risk Evaluation (EuroSCORE) \> 6;
• Able to receive enteral nutrition through nasal/oral gastric or post-pyloric feeding tube.

You may not qualify if:

• Planned heart or lung transplantation
• Planned cardiovascular surgery without cardiopulmonary bypass;
• Peri-operative support with extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD).

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Mazankowski Alberta Heart Institute, University of Alberta

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Conditions

Cross Infection

Interventions

Glutamine; maltodextrin

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Sean Bagshaw

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Gurmeet Singh

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Glutamine

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: October 11, 2012
• Study Start: September 1, 2012
• Primary Completion: June 21, 2016
• Study Completion: June 21, 2016
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

CA (2)