Coronary Artery Disease Clinical Trial
Official title:
Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%
Verified date | April 2019 |
Source | University of Saskatchewan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to determine which priming fluid is the safest for use for priming the heart-lung machine used during cardiopulmonary bypass for patients undergoing cardiac surgery. The fluids to be compared are albumin and voluven. A control group will receive only crystalloid.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: patients undergoing cardiopulmonary bypass assisted cardiac surgery - Exclusion Criteria: emergencies and patients in renal failure or dialysis - |
Country | Name | City | State |
---|---|---|---|
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan |
Canada,
Akkucuk FG, Kanbak M, Ayhan B, Celebioglu B, Aypar U. The effect of HES (130/0.4) usage as the priming solution on renal function in children undergoing cardiac surgery. Ren Fail. 2013;35(2):210-5. doi: 10.3109/0886022X.2012.747139. Epub 2012 Dec 11. — View Citation
Alavi SM, Ahmadi BB, Baharestani B, Babaei T. Comparison of the effects of gelatin, Ringer's solution and a modern hydroxyl ethyl starch solution after coronary artery bypass graft surgery. Cardiovasc J Afr. 2012 Sep;23(8):428-31. doi: 10.5830/CVJA-2012-026. — View Citation
Hartog CS, Reuter D, Loesche W, Hofmann M, Reinhart K. Influence of hydroxyethyl starch (HES) 130/0.4 on hemostasis as measured by viscoelastic device analysis: a systematic review. Intensive Care Med. 2011 Nov;37(11):1725-37. doi: 10.1007/s00134-011-2385-z. Epub 2011 Oct 12. Review. — View Citation
Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D, Glass P, Lipman J, Liu B, McArthur C, McGuinness S, Rajbhandari D, Taylor CB, Webb SA; CHEST Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med. 2012 Nov 15;367(20):1901-11. doi: 10.1056/NEJMoa1209759. Epub 2012 Oct 17. Erratum in: N Engl J Med. 2016 Mar 31;374(13):1298. — View Citation
Navickis RJ, Haynes GR, Wilkes MM. Effect of hydroxyethyl starch on bleeding after cardiopulmonary bypass: a meta-analysis of randomized trials. J Thorac Cardiovasc Surg. 2012 Jul;144(1):223-30. doi: 10.1016/j.jtcvs.2012.04.009. Epub 2012 May 9. — View Citation
Schramko AA, Suojaranta-Ylinen RT, Kuitunen AH, Kukkonen SI, Niemi TT. Rapidly degradable hydroxyethyl starch solutions impair blood coagulation after cardiac surgery: a prospective randomized trial. Anesth Analg. 2009 Jan;108(1):30-6. doi: 10.1213/ane.0b013e31818c1282. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative bleeding and transfusion requirements | Postoperative cardiac patients have chest tubes in place which drain any blood oozing from around the pericardial cavity. The chest tubes are attached to a blood collection apparatus which measures the amount of blood loss. Too much post-operative blood loss results in a transfusion requirement of red blood cells, plasma and/or platelets. | 24-48 hours post-operatively | |
Secondary | renal function, creatinine levels | Use of some colloids have been associated with a deterioration of renal function. Data will be collected post-operatively to determine he effect of the different priming fluids on renal function | 24-48 hours post-operatively |
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