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Clinical and Chemical Outcomes Following Cardiac Surgery: The Post-Operative Effects of MUF (MUF)

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ClinicalTrials.gov Identifier: NCT01864395
Recruitment Status : Unknown
Verified May 2013 by University of Saskatchewan.
Recruitment status was:  Not yet recruiting
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan

Brief Summary:
It is hypothesized that on-line modified ultrafiltration (MUFF) post-cardiopulmonary bypass will result in improved patient outcomes over the 12-hour post-operative period as compared to control and off-line MUFF.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Anemia Procedure: Centrifugation Method Procedure: Online MUF Procedure: Offline MUF Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Clinical and Chemical Outcomes Following Cardiac Surgery: The Post-Operative Effects of Modified Ultrafiltration (On-line MUF) and Off-line (MUF)
Study Start Date : July 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Control (CF)
Centrifugation Method (CF): currently used to separate whole blood into red blood cells (RBCs) and plasma components. The RBCs are washed with normal saline and re-infused into the patient, while the plasma portion is discarded.
Procedure: Centrifugation Method
Currently used to separate whole blood into red blood cells (RBCs) and plasma components. The RBCs are washed with normal saline and re-infused into the patient, while the plasma portion is discarded.

Experimental: Online MUF
Online MUF: hemofilter is used online while the heart-lung machine is connected to the patient.
Procedure: Online MUF
Hemofilter is used online while the heart-lung machine is connected to the patient.

Experimental: Offline MUF
Offline MUF: hemofilter is used offline when the heart-lung machine is not connected to the patient.
Procedure: Offline MUF
Hemofilter is used offline when the heart-lung machine is not connected to the patient.




Primary Outcome Measures :
  1. Post-Operative Volume of Chest Tube Drainage [ Time Frame: 12 hours ]
    Our primary outcome variable is the post-operative volume of chest tube drainage.


Secondary Outcome Measures :
  1. Biochemical Variables [ Time Frame: 12 hours ]
    Biochemical variables include Hb, albumin fibrinogen, and total protein.

  2. Clinical Variables [ Time Frame: 12 hours ]
    Clinical variables include volume of allogeneic transfusion, length of stay in ICU, intubation time, and vasoactive inotrope score.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female
  • patient weighs 75 kg or smaller
  • 40-80 years of age
  • elective or urgent cardiac surgery

Exclusion Criteria:

  • emergent surgery
  • severe anemia
  • severe kidney dysfunction
  • ejection fraction of less than 30%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864395


Contacts
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Contact: Erick D McNair, PhD 1-306-222-7403 erick.mcnair@usask.ca

Locations
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Canada, Saskatchewan
Royal University Hospital Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Erick D McNair, PhD    1-306-222-7403    erick.mcnair@usask.ca   
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Erick D McNair, PhD Clinical Assistant Professor, Department of Surgery, Cardiovascular Surgery

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Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01864395     History of Changes
Other Study ID Numbers: 13-143
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013
Keywords provided by University of Saskatchewan:
cardiovascular surgery
cardiac surgery
cardiopulmonary bypass
IV fluids
blood pressure
heart-lung machine
hemofilter
online MUF
offline MUF
modified ultrafiltration
multiple-pass hemofiltration
centrifugation method
blood transfusion
plasma proteins
post-cardiopulmonary bypass
hemoglobin
clotting factors
systemic blood pressure
cardiac index
cytokines
post-operative bleeding
protamine administration
patient size
allogeneic transfusion
total protein
albumin
vasoactive inotrope score
fluid balance
chest tube loss
length of stay
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases