Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%

NCT01849757 | Withdrawn

• 1 other identifier: ruh/westerncan/primestudy
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease

Keywords

Cardiopulmonary bypass; prime; crystalloid; albumin; HES 130/0.4

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• renal function, creatinine levels

  24-48 hours post-operatively

Study Arms (3)

Human Albumin

ACTIVE COMPARATOR

Human albumin solution used as part of the priming volume for the cardiopulmonary bypass circuit.

Other: Human Albumin

Voluven or hydroethylstarch HES 130/0.4

ACTIVE COMPARATOR

Hydroethylstarch HES 130/0.4 used as part of the priming volume for the cardiopulmonary bypass circuit.

Other: Voluven

Crystalloid

PLACEBO COMPARATOR

Crystalloid will be used to prime the cardiopulmonary bypass circuit

Other: prime crystalloid

Interventions

prime crystalloid OTHER

used for priming the CPB circuit

Also known as: saline 0.9%, Normosol, Ringer's lactate, Plasmalyte

Crystalloid

Human Albumin OTHER

Used as a constituent for priming the CPB circuit

Also known as: Albumin 5%, Albumin 25%

Human Albumin

Voluven OTHER

Used as a constituent for priming the CPB circuit

Also known as: Hydroethylstarch HES130/0.4

Voluven or hydroethylstarch HES 130/0.4

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing cardiopulmonary bypass assisted cardiac surgery

You may not qualify if:

• emergencies and patients in renal failure or dialysis -

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (6)

• 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.

  PMID: 23075127 BACKGROUND

• 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.

  PMID: 22578894 BACKGROUND

• 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.

  PMID: 21989733 BACKGROUND

• 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.

  PMID: 19095827 BACKGROUND

• 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.

  PMID: 23228215 BACKGROUND

• 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.

  PMID: 23044498 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Disease

Interventions

Sodium Chloride; normosol R; Ringer's Lactate; Plasmalyte A; Serum Albumin, Human; zidovudine 5'-monophosphate-mannose-albumin conjugate; HES 130-0.4

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Jo-Anne E Marcocoux, M. Sc.

  Royal University Hospital Foundation

  PRINCIPAL INVESTIGATOR

• Jo-Anne E Marcoux, M. Sc.

  RUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Perfusionist M. Sc., CPC, CCP

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: May 3, 2019

Record last verified: 2019-04

Locations

CA (1)