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Glutamate for Metabolic Intervention in Coronary Surgery II

NCT02592824 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2023-12-04

Study results available
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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.

Conditions

  • Coronary Artery Bypass Surgery
  • Postoperative Complications
  • Heart Failure

Interventions

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.

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.

Sponsors & Collaborators

  • Region Örebro County

    collaborator OTHER

  • University Hospital, Umeå

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Rolf Svedjeholm, Professor · University Hospital, Linkoeping

  • Farkas Vanky, MD, PhD · University Hospital, Linkoeping

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-15
Primary Completion
2020-10-30
Completion
2020-10-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02592824 on ClinicalTrials.gov