Comparison of Blood Cardioplegia and Custodiol

NCT01941459 | Completed

• 1 other identifier: 2007-001780-30
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Thru the last 20 years it has been a discussion witch solution that gives the best myocardial protection during cardiac arrest by heart operations.

• It has been a tendency that a blood based cardioplegia gives a better protection bye long ischemic times but it has not been possible too conclude in this matter.
• The investigators have two groups of cardioplegia, the blood based and, the crystalloid based cardioplegia.
• It has been done a lot of studies to see what kind of cardioplegia that gives the best myocardial protection. Different temperature, different amount and content, retrograde or antegrade or both, contentiously and further on have been tested without a clear conclusion.
• The investigators decided to make a study with a cohort of patients as homogenous as possible with a cross clamp time around 70 min.
• Adult patients' with a severe aortic stenoses without any other significant heart disease was included in our prospective randomised study.
• Patients with additional significant coronary artery disease (≥ 50% stenoses) were excluded from the study.
• The investigators used the well known biomarkers CK-MB and troponin-T too evaluate the myocardial damage.

Conditions

Mitral Insufficiencies; Myocardial Protection

Keywords

CK-MB; troponin-T

Outcome Measures

Primary Outcomes (1)

• CK-MB ,troponin-T

  72 hours

Study Arms (2)

1 Custodiol

Custodiol

2 Blood cardioplegia

Blood cardioplegia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between Mars 2007 and December 2009, 80 consecutive patients undergoing elective mitral valve surgery for mitral regurgitation at Oslo University Hospital Ullevål, Oslo, Norway and Sahlgrenska University Hospital, Gothenburg, Sweden were included in the study after informed written consent.

You may not qualify if:

• Patients with any other concomitant heart valve disease or coronary artery stenoses (≥ 50%) were excluded from the study.
• Age below 18
• Pregnant

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

thoraxkirurgisk avd, UUS

Oslo, Norway

Location

Study Officials

• Theis Tønnessen, prof.dr.med

  Thoraxkirurgisk avd. UUS

  STUDY DIRECTOR

• Bjørn Braathen, med.doc

  Thoraxkir.avd. UUS

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Ph.D

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: September 13, 2013
• Study Start: March 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: September 13, 2013

Record last verified: 2013-09

Locations

NO (1)