NCT01348906

Brief Summary

This study aims to determine the effect of intermittent normoxic cardiopulmonary bypass (CPB) on inflammatory response, oxidative stress and myocardial reperfusion injury in adult patients undergoing valve replacement. The investigators hypothesized that nuclear factor kappa B (NFkB) was involved in regulating gene expression of myocardial inflammatory factor.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 6, 2011

Status Verified

May 1, 2011

Enrollment Period

2 months

First QC Date

May 3, 2011

Last Update Submit

May 5, 2011

Conditions

Hyperoxia

Keywords

cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • plasma concentration of troponin I

    within the first 24h after cardiac surgery

Secondary Outcomes (1)

  • gene expression of TNFa, IL-6, and IL-10 in myocardium

    30 min after aotic de-clamping

Study Arms (1)

Intermittent normoxia

EXPERIMENTAL

Repeated brief normoxic reperfusion during cardioplegia arrest in adult valve replacement

Procedure: intermittent normoxia

Interventions

intermittent normoxiaPROCEDURE

3 cycles of 5/5 min normoxia/hyperoxic reperfusion during cardioplegia arrest in adult valve replacement

Intermittent normoxia

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement

You may not qualify if:

  • infective endocarditis congenital valve disease previous cardiac surgery complicated with diabetes, coronary artery disease, hypertension or peripheral vascular disease.
  • receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery, Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Shengxi Chen, M.D.

CONTACT

86-731-89753413shengxi.chen@hotmail.com

Li Li, M.D.

CONTACT

86-731-84327097lovelily0920@yahoo.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2011

First Posted

May 6, 2011

Study Start

May 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 6, 2011

Record last verified: 2011-05

Locations

CN(1)