Intravenous glutamate infusion to prevent heart failure after coronary surgery

GLUTAmate for Metabolic Intervention in Coronary Surgery II - GLUTAMICS II

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006241-15-SE

Enrollment

1400

Registered

2011-12-27

Start date

2012-02-15

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina CCS class IV treated with coronary artery bypass surgery Coronary artery disease with moderate to severe left ventricular dysfunction treated with coronary artery bypass surgery MedDRA version: 14.1 Level: LLT Classification code 10068176 Term: Coronary artery bypass graft System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: L-glutamic acid Pharmaceutical Form: Solution for infusion Other descriptive name: MONOSODIUM L-GLUTAMATE Concentration unit: mg/l milligram(s)/litre Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Angina CCS class IV treated with coronary artery bypass surgery Coronary artery disease with moderate to severe left ventricular dysfunction treated with coronary artery bypass surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 900

Exclusion criteria

Exclusion criteria: Informed consent not possible because of critical condition, informed consent not possible because of or other reason, preoperative use of inotropic drugs or mechanical circulatory assist, preoperative dialysis or p-creatinine > 250 µmol/l, redo-procedure, patients having concomitant valve procedure or ablation for atrial fibrillation, unexpected intraoperative finding or event that increases the dignity of the procedure to overshadow the originally planned operation, age > 85 years, and food allergy known to have caused flush, rash or asthma.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if intravenous glutamate infusion given in association with coronary artery bypass surgery can prevent or mitigate postoperative heart failure that leads to prolonged stay in intensive care, renal failure or death. ;Secondary Objective: To address the safety of the intravenous glutamate infusion.;Primary end point(s): The primary end point is a composite of a) cardiac mortality (30-days or in-hospital) b) severe postoperative heart failure according to prespecified criteria c) renal failure (increase of p-creatinine x2 or new onset dialysis postoperatively) The criteria for severe postoperative heart failure are postoperative heart failure requiring = 3 days stay in intensive care with inotropic drugs running 48 hours postoperatively and at least for 24 hours in prespecified dosages.;Timepoint(s) of evaluation of this end point: 30 days or first hospitalization (including referral hospital and the hospital where surgery is performed)	—

Measure

Time frame

Main Objective: To investigate if intravenous glutamate infusion given in association with coronary artery bypass surgery can prevent or mitigate postoperative heart failure that leads to prolonged stay in intensive care, renal failure or death. ;Secondary Objective: To address the safety of the intravenous glutamate infusion.;Primary end point(s): The primary end point is a composite of a) cardiac mortality (30-days or in-hospital) b) severe postoperative heart failure according to prespecified criteria c) renal failure (increase of p-creatinine x2 or new onset dialysis postoperatively) The criteria for severe postoperative heart failure are postoperative heart failure requiring = 3 days stay in intensive care with inotropic drugs running 48 hours postoperatively and at least for 24 hours in prespecified dosages.;Timepoint(s) of evaluation of this end point: 30 days or first hospitalization (including referral hospital and the hospital where surgery is performed)

—

Secondary

Measure	Time frame
Secondary end point(s): Safety of the intervention.;Timepoint(s) of evaluation of this end point: Hospitalization at the hospital where surgery is performed.	—

Countries

Sweden

Contacts

Public ContactDept Cardiothoracic Surgery

Linköping University Hospital

rolf.svedjeholm@lio.se46101034825

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026