NCT01548872

Brief Summary

The purpose of this study is to compare two different cardioplegia solutions effect on postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.

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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 6, 2012

Last Update Submit

March 6, 2012

Conditions

Myocardial Injury

Keywords

HTk solutionCardioplegiamyocardial protectionpediatric cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • myocardial protective effect of HTK solution

    to detect %33 difference in Troponin-I levels 4 hours postoperatively

    postoperative 48 hours

Secondary Outcomes (1)

  • hemodynamic and respiratory data

    postoperative 48 hours

Study Arms (2)

crystalloid cardioplegia solution

ACTIVE COMPARATOR

After aortic cross clamp 30ml/kg will be administered

Drug: crystalloid cardioplegia solution

HTK solution

ACTIVE COMPARATOR

After aortic cross clamp 50ml/kg will be administered

Drug: HTK solution

Interventions

HTK solutionDRUG

50 ml/kg bolus in 2 minutes

HTK solution
crystalloid cardioplegia solutionDRUG

30 ml/kg bolus in two minutes

crystalloid cardioplegia solution

Eligibility Criteria

Age1 Month - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients scheduled for elective pediatric cardiac surgery
  • Patients written informed consent for study participation

You may not qualify if:

  • redo surgery
  • allergy to study drugs
  • unstable blood pressure before cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University, Faculty of Medicine

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Bretschneider cardioplegic solutionpotassium cardioplegic solution

Central Study Contacts

Selim Kuşlu

CONTACT

+90 312 212 68 68selimkuslu@gmail.com

Pınar Zeyneloğlu

CONTACT

+ 90 312 212 68 68pinar.zeyneloglu@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology Resident

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 8, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

TU(1)