Clinical and Chemical Outcomes Following Cardiac Surgery: The Post-Operative Effects of MUF
MUF
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jul 2013
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMay 29, 2013
May 1, 2013
1 year
May 14, 2013
May 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-Operative Volume of Chest Tube Drainage
Our primary outcome variable is the post-operative volume of chest tube drainage.
12 hours
Secondary Outcomes (2)
Biochemical Variables
12 hours
Clinical Variables
12 hours
Study Arms (3)
Control (CF)
EXPERIMENTALCentrifugation 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.
Online MUF
EXPERIMENTALOnline MUF: hemofilter is used online while the heart-lung machine is connected to the patient.
Offline MUF
EXPERIMENTALOffline MUF: hemofilter is used offline when the heart-lung machine is not connected to the patient.
Interventions
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.
Hemofilter is used online while the heart-lung machine is connected to the patient.
Hemofilter is used offline when the heart-lung machine is not connected to the patient.
Eligibility Criteria
You may qualify if:
- male and female
- patient weighs 75 kg or smaller
- years of age
- elective or urgent cardiac surgery
You may not qualify if:
- emergent surgery
- severe anemia
- severe kidney dysfunction
- ejection fraction of less than 30%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erick D McNair, PhD
Clinical Assistant Professor, Department of Surgery, Cardiovascular Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2013
First Posted
May 29, 2013
Study Start
July 1, 2013
Primary Completion
July 1, 2014
Study Completion
October 1, 2014
Last Updated
May 29, 2013
Record last verified: 2013-05