Hemodilution and Outcome in Cardiac Surgery

Kidney Failure Clinical Trial

Official title:

Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00364494
• Other study ID #: DS/URC/ER/mm 556/DG
• Status: Terminated
• Phase: N/A
• First received: August 11, 2006
• Last updated: August 13, 2009
• Start date: November 2006
• Est. completion date: April 2007

Study information

• Verified date: August 2009
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intraoperative Complications
• Kidney Failure
• Renal Insufficiency

Intervention

Procedure:
• Different 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

Locations

Country	Name	City	State
Italy	Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function
Secondary	other organ damage
Secondary	prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
Secondary	sepsis
Secondary	exitus