NCT01794884

Brief Summary

In view of the lack of large-scale clinical study and potent evidence-based medicine, the investigators designed a randomized, double-blind, placebo-controlled study to ascertain whether preoperative intravenous administration with glutamine can improve the postoperative cardiac function and prognosis of adult patients undergoing cardiac surgery. The investigators want to detect the levels of myocardial protein O-GlcNAc modification and HSP70 expression, changes in sensitive indicators of myocardial injury, systemic inflammatory reaction and oxidative stress levels, and to examine the correlation between these changes and Clinical manifestations. The ultimate goal of the study is to explore a new way for clinical myocardial protection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

February 4, 2013

Last Update Submit

May 27, 2014

Conditions

Rheumatic Heart DiseaseCoronary Heart Disease

Keywords

GlutamineCardiosurgeryCardiopulmonary bypassCardiac functionRecovery

Outcome Measures

Primary Outcomes (1)

  • perioperative changes of Cardiac Index (CI)

    For each patient,a Swan-Ganz catheter will be inserted after anesthesia induction.CI and other values of hemodynamics will be measured.

    postanescesia before surgery, 2, 20 hours after cardiopulmonary bypass (CPB)

Secondary Outcomes (6)

  • Troponin I(cTnI)

    postanescesia before surgery, 6, 20 hours after CPB

  • Brain Natriuretic Peptide (BNP)

    postanescesia before surgery, 6, 20 hours after CPB

  • Systemic inflammation

    postanescesia before surgery, 2, 20 hours after CPB

  • Heart issue HSP-70

    20 minutes after CPB

  • Heart issue O-GlcNAc

    20 minutes after CPB

  • +1 more secondary outcomes

Study Arms (2)

Glutamine

EXPERIMENTAL

20% N(2)-L-alanyl-L-glutamine 0.4g/kg(2ml/kg) mixed with compound amino acid (10ml/kg)(volume ratio=1:5).Intravenous injection twice (24 hours、1 hour before operation).

Drug: Glutamine

Ringer's solution

PLACEBO COMPARATOR

Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation).

Drug: Ringer's solution

Interventions

GlutamineDRUG

20% N(2)-L-alanyl-L-glutamine 0.4g/kg(2ml/kg) mixed with compound amino acid (10ml/kg).Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h

Also known as: Dipeptiven (N(2)-L-Alanine L-Glutamine dipeptide)
Glutamine
Ringer's solutionDRUG

Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h.

Ringer's solution

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with coronary artery disease or rheumatic heart disease accepted cardiosurgery under cardiopulmonary bypass

You may not qualify if:

  • ejection fraction(EF)\<50%
  • Preoperative support with intra-aortic balloon pump(IABP)
  • Hepatosis
  • Renal dysfunction
  • Myocardial infarction attack within 3 months
  • Emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Rheumatic Heart DiseaseCoronary Disease

Interventions

GlutaminealanylglutamineRinger's Solution

Condition Hierarchy (Ancestors)

Rheumatic FeverStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, NeutralIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 20, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

CN(1)