Back to resultsHemodilution and Outcome in Cardiac Surgery
Primary Purpose
Kidney Failure, Intraoperative Complications
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Failure focused on measuring Hematocrit, Hemodilution, Blood Transfusion, Cardiopulmonary Bypass, Multiple Organ Failure, Surgery, Cardiac, Kidney Failure, Cardiac Surgical Procedures
Eligibility Criteria
Inclusion Criteria: Undergoing cardiac surgery Exclusion Criteria: Age < 18 years old Not signing written consent Age < 65 years old (subgroup 1) Emergency, aortic stenosis, main left coronary stenosis (subgroup 2)
Sites / Locations
- Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Outcomes
Primary Outcome Measures
renal function
Secondary Outcome Measures
other organ damage
prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
sepsis
exitus
Full Information
NCT ID
NCT00364494
First Posted
August 11, 2006
Last Updated
August 13, 2009
Sponsor
Università Vita-Salute San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT00364494
Brief Title
Hemodilution and Outcome in Cardiac Surgery
Official Title
Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
difficult enrollment after the primary investigator left the centre
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Università Vita-Salute San Raffaele
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An hematocrit of 21-25% is supposed to perform the best organ protection during cardiopulmonary bypass for cardiac surgery.
The investigators want to establish the best timing for a transfusion (in patients with a predicted low hematocrit during cardiopulmonary bypass) and the efficacy of preprocedural hemodilution (in patients with a predicted high hematocrit during cardiopulmonary bypass) in patients undergoing cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Intraoperative Complications
Keywords
Hematocrit, Hemodilution, Blood Transfusion, Cardiopulmonary Bypass, Multiple Organ Failure, Surgery, Cardiac, Kidney Failure, Cardiac Surgical Procedures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)
Intervention Description
Subgroup 1,with Ht<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht>25% bleed or not
Primary Outcome Measure Information:
Title
renal function
Secondary Outcome Measure Information:
Title
other organ damage
Title
prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
Title
sepsis
Title
exitus
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing cardiac surgery
Exclusion Criteria:
Age < 18 years old
Not signing written consent
Age < 65 years old (subgroup 1)
Emergency, aortic stenosis, main left coronary stenosis (subgroup 2)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Landoni, MD
Organizational Affiliation
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giuseppe Crescenzi, MD
Organizational Affiliation
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
City
Milano
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
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Hemodilution and Outcome in Cardiac Surgery
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