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Trial record 2 of 2 for:    glutamics

Glutamate for Metabolic Intervention in Coronary Surgery II (GLUTAMICSII)

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ClinicalTrials.gov Identifier: NCT02592824
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : November 12, 2020
Sponsor:
Collaborators:
Region Örebro County
University Hospital, Umeå
Sahlgrenska University Hospital, Sweden
Blekinge County Council Hospital
Uppsala University Hospital, Sweden
Information provided by (Responsible Party):
Rolf Svedjeholm, University Hospital, Linkoeping

Brief Summary:
The aim of GLUTAMICS II is to evaluate whether intravenous glutamate infusion surgery reduces the risk of postoperative heart failure as measured by plasma NT-proBNP in patients undergoing moderate to high-risk coronary artery bypass graft surgery. Patients accepted for coronary artery bypass surgery of at least two vessel disease or left main stenosis with or without concomitant procedure and considered to be at moderate to high surgical risk preoperatively with regard to postoperative heart failure will be studied. The primary endpoint is postoperative increase of NT-proBNP from the day before surgery to the third postoperative day.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Surgery Postoperative Complications Heart Failure Drug: glutamate infusion Drug: saline infusion Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase III Study of Metabolic Intervention With Glutamate in Coronary Surgery II
Actual Study Start Date : November 15, 2015
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intravenous glutamate infusion
Intravenous infusion of 0.125M L-glutamic acid solution at a rate of 1.65 ml/kg BW and hour commencing at or up to 20 minutes before the release of aortic cross-clamp. The infusion is continued for two hours after declamping the aorta after which an additional 50 ml is given at a halved infusion rate.
Drug: glutamate infusion
Intravenous infusion of 0.125M L-glutamic acid solution at a rate of 1.65 ml/kg BW and hour commencing at or up to 20 minutes before the release of aortic cross-clamp. The infusion is continued for two hours after declamping the aorta after which an additional 50 ml is given at a halved infusion rate.
Other Name: glutamate

Placebo Comparator: Intravenous saline infusion
Intravenous infusion of saline at a rate of 1.65 ml/kg BW and hour commencing at or up to 20 minutes before the release of aortic cross-clamp. The infusion is continued for two hours after declamping the aorta after which an additional 50 ml is given at a halved infusion rate.
Drug: saline infusion
Intravenous infusion of saline at a rate of 1.65 ml/kg BW and hour commencing at or up to 20 minutes before the release of aortic cross-clamp. The infusion is continued for two hours after declamping the aorta after which an additional 50 ml is given at a halved infusion rate.
Other Name: saline




Primary Outcome Measures :
  1. postoperative increase of plasma NT-proBNP [ Time Frame: from the day before surgery to the third postoperative day ]

Secondary Outcome Measures :
  1. postoperative plasma level of NT-proBNP [ Time Frame: first postoperative day ]
  2. postoperative plasma level of NT-proBNP [ Time Frame: third postoperative day ]
  3. Incidence of Stroke [ Time Frame: within 24 hours from surgery ]
  4. Incidence of Mortality [ Time Frame: up to 30 days ]
  5. Incidence of unexpected adverse events [ Time Frame: within 24 hours from infusion ]
    suspected unexpected serious adverse reaction


Other Outcome Measures:
  1. Copeptin substudy [ Time Frame: preoperative, first and third postoperative day ]
    Exploratory assessment of plasma-Copeptin related to NT-proBNP



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients accepted for coronary artery bypass surgery of at least two vessel disease or left main stenosis with or without concomitant procedure considered to be at moderate to high surgical risk preoperatively with regard to postoperative heart failure due to:

• EuroSCORE II ≥ 3.0 with at least one of the following cardiac or procedure related risk factors:

  • LVEF ≤ 0.50
  • CCS class IV
  • Recent Myocardial Infarct (≤ 90 days)
  • Emergency / Urgent procedure (as defined in EuroSCORE II)
  • CABG with aortic or mitral valve procedure

OR

• LVEF ≤ 0.30 regardless of EuroSCORE II

Exclusion Criteria:

  • age > 85 years
  • ambiguous food allergies that trigger shortness of breath, headache or flushing
  • previous cardiac surgery
  • patients who are in such bad condition that they cannot be asked to participate
  • patients who because of linguistic or other reasons are unable to provide informed consent
  • severe renal failure with preoperative dialysis or calculated GFR <30 mL / min
  • patients requiring mechanical circulatory support (intra-aortic balloon pump) due to circulatory failure before they are enrolled in the study
  • surgery without heart-lung machine (off-pump)
  • concomitant Maze-procedure
  • surgery of ascending aorta
  • surgery of both aortic and mitral valve

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): NCT02592824


Locations
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Sweden
Uppsala University Hospital
Uppsala, Uppland, Sweden, SE75185
Sahlgrenska University Hospital
Gothenburg, Sweden, SE41345
Blekinge County Council Hospital
Karlskrona, Sweden, SE37185
University Hospital Linköping
Linköping, Sweden, SE58185
University Hospital Umeå
Umeå, Sweden, SE90185
University Hospital Örebro
Örebro, Sweden, SE 70185
Sponsors and Collaborators
University Hospital, Linkoeping
Region Örebro County
University Hospital, Umeå
Sahlgrenska University Hospital, Sweden
Blekinge County Council Hospital
Uppsala University Hospital, Sweden
Investigators
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Study Chair: Rolf Svedjeholm, Professor University Hospital, Linkoeping
Publications:

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Responsible Party: Rolf Svedjeholm, Professor, MD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT02592824    
Other Study ID Numbers: EudraCT 2011-006241-15
Dnr 5.1-2015-77379 ( Other Identifier: Swedish Medical Product Agency )
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Keywords provided by Rolf Svedjeholm, University Hospital, Linkoeping:
glutamate, heart failure, coronary artery bypass surgery
Additional relevant MeSH terms:
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Heart Failure
Postoperative Complications
Heart Diseases
Cardiovascular Diseases
Pathologic Processes