Hemodilution and Outcome in Cardiac Surgery

Not Applicable

Terminated

• Conditions: Kidney Failure; Intraoperative Complications

• Registration Number: NCT00364494
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Study Start: 2006-11
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-13
• Last Update Posted: 2009-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
renal function

Secondary Outcome Measures

Name	Time	Method
sepsis
other organ damage
prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
exitus

Trial Locations

Locations (1)

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia; 🇮🇹 Milano, Italy