Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01704430
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2012-08-22
Brief Title:
Glutamine to Improve Outcomes in Cardiac Surgery
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
GLutamine Enterally After carDiac Surgery for Inflammation Attenuation and ouTcOme impRovement GLADIATOR A Phase II Randomized Blinded Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLADIATOR
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
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
Detailed Description:
Hypothesis We believe that early post-operative administration of enteral glutamine following cardiac surgery with cardiopulmonary bypass CPB in high risk patients will reduce inflammation and nonscomial infections reduce length of ventilator support reduce need for vasoactive support reduce secondary organ dysfunction reduce length of hospital stay in the CVICU and reduce mortality
Objectives
To assess the feasibility of early glutamine supplementation
To evaluate the safety profile of early glutamine supplementation
To evaluate efficacy the impact of early glutamine on clinically important post-operative complications and outcomes including systemic inflammation nosocomial infections mortality and health resource utilization
Methods Study Design Setting and Patient Population The proposed study is a Phase II randomized blinded placebo-controlled trial This trial will be performed in the Cardiovascular Surgical Intensive Care Unit CVICU of the Mazankowski Alberta Heart Institute MAHI Alberta Health Services The proposed trial plans to enroll 100 consecutive eligible patients
Inclusion
Consent obtained pre-operatively
Adult - aged 18 years or older
Planned cardiac surgery with CPB
Elevated 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 nasaloral gastric or post-pyloric feeding tube
Exclusion
Planned heart or lung transplantation
Planned cardiac surgery without cardiopulmonary bypass
Peri-operative support with extracorporeal membrane oxygenation ECMO or left ventricular assist device LVAD
Study Protocol Eligible patients will be identified during pre-operative assessment in the pre-operative clinic PAC All eligible patients or their surrogate decision-makinglegal guardian will then be approached to obtain informed written consent
Each consenting participant will be randomly allocated 11 to receive post-operative enteral glutamine or identical placebo Investigators surgeons intensivists bedside nurses and participants will remain blinded to study allocation
Glutamine supplementation will be dosed at 05 gkg satisfactory body weight SBWday divided every 8 hours starting 6 hours post-operatively and continued for 5 days The dose of 05 gkg SBWday was effective in clinical studies using enteral glutamine in critically ill andor burn injured and major trauma patients The glutamine supplementation or placebo will be delivered via naso- or oro-gastric feeding tube after confirmation of placement by chest X-ray For participants who are extubated prior to 5 days enteral glutamine will be given by mouth for the duration of the 5 day period Glutamine and placebo will be mixed in orange juice to maintain blinding
Objectives
To assess the feasibility of early glutamine supplementation
To evaluate the safety profile of early glutamine supplementation
To evaluate efficacy the impact of early glutamine on clinically important post-operative complications and outcomes including systemic inflammation nosocomial infections mortality and health resource utilization
Methods Study Design Setting and Patient Population The proposed study is a Phase II randomized blinded placebo-controlled trial This trial will be performed in the Cardiovascular Surgical Intensive Care Unit CVICU of the Mazankowski Alberta Heart Institute MAHI Alberta Health Services The proposed trial plans to enroll 100 consecutive eligible patients
Inclusion
Consent obtained pre-operatively
Adult - aged 18 years or older
Planned cardiac surgery with CPB
Elevated 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 nasaloral gastric or post-pyloric feeding tube
Exclusion
Planned heart or lung transplantation
Planned cardiac surgery without cardiopulmonary bypass
Peri-operative support with extracorporeal membrane oxygenation ECMO or left ventricular assist device LVAD
Study Protocol Eligible patients will be identified during pre-operative assessment in the pre-operative clinic PAC All eligible patients or their surrogate decision-makinglegal guardian will then be approached to obtain informed written consent
Each consenting participant will be randomly allocated 11 to receive post-operative enteral glutamine or identical placebo Investigators surgeons intensivists bedside nurses and participants will remain blinded to study allocation
Glutamine supplementation will be dosed at 05 gkg satisfactory body weight SBWday divided every 8 hours starting 6 hours post-operatively and continued for 5 days The dose of 05 gkg SBWday was effective in clinical studies using enteral glutamine in critically ill andor burn injured and major trauma patients The glutamine supplementation or placebo will be delivered via naso- or oro-gastric feeding tube after confirmation of placement by chest X-ray For participants who are extubated prior to 5 days enteral glutamine will be given by mouth for the duration of the 5 day period Glutamine and placebo will be mixed in orange juice to maintain blinding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None