Intraoperative Complications, Kidney Failure
Conditions
Keywords
Hematocrit, Hemodilution, Blood Transfusion, Cardiopulmonary Bypass, Multiple Organ Failure, Surgery, Cardiac, Kidney Failure, Cardiac Surgical Procedures
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.
Interventions
PROCEDUREDifferent timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)
Subgroup 1,with Ht\<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht\>25% bleed or not
Sponsors
Università Vita-Salute San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal function | — |
Secondary
| Measure | Time frame |
|---|---|
| other organ damage | — |
| prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay | — |
| sepsis | — |
| exitus | — |
Countries
Italy
Outcome results
None listed