Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
380
Countries
1
Sites
5
Acute kidney injury and heart failure after coronary artery bypass surgery in patients without diabetes
To establish the efficacy of intravenous glutamate infusion to prevent acute kidney injury (AKI) after coronary artery bypass surgery (CABG) among high-risk patients without diabetes.
Key facts
- Sponsor
- Region Oestergoetland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2024-09-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Therapy
To establish the efficacy of intravenous glutamate infusion to prevent acute kidney injury (AKI) after coronary artery bypass surgery (CABG) among high-risk patients without diabetes.
Secondary objectives 3
- To establish the efficacy of intravenous glutamate infusion to mitigate postoperative increase of NT-proBN after coronary artery bypass surgery among high-risk patients without diabetes
- To assess the impact of glutamate infusion on biomarkers of tubular kidney injury after CABG among high-risk patients without diabetes
- To assess the impact of perioperative glutamate infusion on kidney function 6 months following CABG
Conditions and MedDRA coding
Acute kidney injury and heart failure after coronary artery bypass surgery in patients without diabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | PT | 10069339 | Acute kidney injury | 100000004857 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Glutamate infusion for prevention of Acute Kidney Injury in surgery for ischemic heart disease Prospective double-blind placebo-controlled trial where patients are randomized 1:1 to receive intravenous infusion of glutamate or placebo in association with CABG. Details in the Clinical Trial Protocol.
|
Randomised Controlled | Double | [{"id":183617,"code":4,"name":"Analyst"},{"id":183613,"code":5,"name":"Carer"},{"id":183614,"code":1,"name":"Subject"},{"id":183615,"code":3,"name":"Monitor"},{"id":183616,"code":2,"name":"Investigator"}] |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- All individual participant data collected during the trial, will be shared after deidentification. In addition, Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code will be shared. Data will be made available upon reasonable request for researchers whose proposed use has been approved and who meet the criteria for access to confidential data. Data will be made available beginning 3 months after publication and ending 5 years after publication. Proposals should be made to the sponsor farkas.vanky @regionostergotland.se or the head of the department of Thoracic and Vascular Surgery at Linköping University Hospital [email protected]
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513575-40-00 | Glutamate infusion for prevention of Acute Kidney Injury in surgery for ischemic heart disease: (GLUTAMICS III = GLUTAmate for Metabolic Intervention in Coronary Surgery III) | Region Oestergoetland |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adult patients without diabetes operated on heart-lung machine with CABG of at least two vessel disease or left main stenosis with or without a concomitant procedure and who either have EuroSCORE II ≥ 3.0 to which at least one cardiac or procedure related risk factor contribute or Left Ventricular Ejection Fraction ≤ 0.30 regardless of EuroSCORE II
Exclusion criteria 1
- Diabetes; ambiguous food allergy known to have elicited flushing, headache, rash or asthma; age > 85 years; previous cardiac surgery; informed consent not possible because of critical condition or other reason; preoperative use of inotropic support or mechanical circulatory assist; preoperative dialysis or calculated Creatinine clearance < 30 mL/min; surgery without heart-lung machine (off-pump); concomitant Maze-procedure; surgery of ascending aorta necessitating circulatory arrest; surgery of both aortic and mitral valve.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence of postoperative acute kidney injury (AKI) measured as >= 50% postoperative increase of p-creatinine compared to preoperative value
Secondary endpoints 3
- Postoperative increase of p-NT-proBNP from the day before surgery to the third postoperative day
- Plasma - neutrophil gelatinase–associated lipocalin (NGAL) on postoperative day 3
- Estimated creatinine clearance (Cockcroft–Gault) at 6 months following surgery related to preoperative level
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB35454 · Substance
- Active substance
- L-Glutamic Acid
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 9 g gram(s)
- Max total dose
- 9 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB35454 · Substance
- Active substance
- L-Glutamic Acid
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 ml millilitre(s)
- Max total dose
- 500 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 ml millilitre(s)
- Max total dose
- 500 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Oestergoetland
- Sponsor organisation
- Region Oestergoetland
- Address
- Universitetssjukhuset I Linkoping
- City
- Linkoping
- Postcode
- 581 85
- Country
- Sweden
Scientific contact point
- Organisation
- Region Oestergoetland
- Contact name
- Farkas Vanky
Public contact point
- Organisation
- Region Oestergoetland
- Contact name
- Farkas Vanky
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 380 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Uppsala University Hospital
Thoraxkliniken, Akademiska Sjukhuset, 751 85, Uppsala
Region Oestergoetland
Thorax-kärlkliniken, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Region Oerebro Laen
Kärl och Thorax, Sodra Grev Rosengatan, 701 85, Orebro
Region Skane Skanes Universitetssjukhus
Thorax & Kärl, Entregatan 7, 222 42, Lund
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Thorax, Bla Straket 5, 413 46, Goteborg
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Clincal Trial Protocol GLUTAMICS III 2024-513575-40-00 | 1 |
| Protocol (for publication) | Clinical Trial Protocol GLUTAMICS III 2024-513575-40-01 SM1 CHANGES YELLOWMARKED | 2 |
| Protocol (for publication) | Clinical Trial Protocol GLUTAMICS III 2024-513575-40-01 SM1 CLEAN | 2 |
| Recruitment arrangements (for publication) | Rekrytering | 1 |
| Subject information and informed consent form (for publication) | Patientinformation version 2 GLUTAMICS III 2024-513575-40-01 SM1 CLEAN | 2 |
| Subject information and informed consent form (for publication) | Patientinformation version 2 GLUTAMICS III 2024-513575-40-01 SM1 YELLOWMARKED | 2 |
| Subject information and informed consent form (for publication) | PatientinformationGLUTAMICS_III_2024-513575-40-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC glutamat CTIS version 1 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC glutamat CTIS version 1 | 1 |
| Synopsis of the protocol (for publication) | Svensk Synopsis GLUTAMICS III 2024-513575-40-01 SM1 CHANGES YELLOWMARKED | 2 |
| Synopsis of the protocol (for publication) | Svensk Synopsis GLUTAMICS III 2024-513575-40-01 SM1 CLEAN | 2 |
| Synopsis of the protocol (for publication) | Svensk synopsis GLUTAMICSIII_2024-513575-40-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-17 | Sweden | Acceptable 2024-08-28
|
2024-09-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-28 | Sweden | Acceptable 2026-06-03
|
2026-06-04 |