Hemodilution and Outcome in Cardiac Surgery

This study is currently recruiting participants.

Verified by Università Vita-Salute San Raffaele, December 2008

First Received: August 11, 2006 Last Updated: December 8, 2008 History of Changes

Sponsored by:	Università Vita-Salute San Raffaele
Information provided by:	Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:	NCT00364494

Purpose

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.

Condition	Intervention
Kidney Failure Intraoperative Complications	Procedure: Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)

MedlinePlus related topics: Blood Transfusion and Donation Heart Surgery Kidney Failure Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:

renal function

Secondary Outcome Measures:

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

Study Start Date:	November 2006
Estimated Study Completion Date:	March 2010

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364494

Contacts

Contact: Giovanni Landoni, MD

+39.347.2520801

landoni.giovanni@hsr.it

Locations

Italy
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia	Recruiting
Milano, Italy, 20132

Sponsors and Collaborators

Università Vita-Salute San Raffaele

Investigators

Study Director:	Giovanni Landoni, MD	Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Principal Investigator:	Giuseppe Crescenzi, MD	Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

More Information

No publications provided

Study ID Numbers:	DS/URC/ER/mm 556/DG
Study First Received:	August 11, 2006
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00364494 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:

Hematocrit
Hemodilution
Blood Transfusion
Cardiopulmonary Bypass

Multiple Organ Failure
Surgery, Cardiac
Kidney Failure
Cardiac Surgical Procedures

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Multiple Organ Failure

Kidney Diseases
Intraoperative Complications
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Pathologic Processes
Urologic Diseases

Kidney Diseases
Intraoperative Complications
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009