Kidney FailureNCT00364494
Hemodilution and Outcome in Cardiac Surgery
A study testing Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2) in people with Kidney Failure and Intraoperative Complications, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Intraoperative Complications
- What is being tested?
- Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Nov 2006to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing cardiac surgery
Who cannot join
- Age < 18 years old
- Not signing written consent
- Age < 65 years old (subgroup 1)
- Emergency, aortic stenosis, main left coronary stenosis (subgroup 2)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Milan, 20132
About this study
Official title: Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery
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.
- Conditions
- Kidney Failure, Intraoperative Complications
- Being tested
- Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)
- Keywords
- Hematocrit, Hemodilution, Blood Transfusion, Cardiopulmonary Bypass, Multiple Organ Failure, Surgery, Cardiac, Kidney Failure, Cardiac Surgical Procedures
- Medical subject headings
- Renal Insufficiency, Intraoperative Complications, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)Procedure or surgery
Subgroup 1,with Ht<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht>25% bleed or not
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function
Secondary outcomes (4)
other organ damage
prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
sepsis
exitus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startNov 2006
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: difficult enrollment after the primary investigator left the centre
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Landoni, MD, Study director, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, ItaliaGiuseppe Crescenzi, MD, Principal investigator, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364494
- Sponsor's protocol ID
- DS/URC/ER/mm 556/DG
- Status last verified
- Aug 2009
- First submitted
- 11 Aug 2006
- Last updated
- 14 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00364494
- Acronym / sponsor ID
- DS/URC/ER/mm 556/DG
- Conditions
- Kidney Failure, Intraoperative Complications
- Keywords
- Hematocrit, Hemodilution, Blood Transfusion, Cardiopulmonary Bypass, Multiple Organ Failure, Surgery, Cardiac, Kidney Failure, Cardiac Surgical Procedures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult enrollment after the primary investigator left the centre
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing cardiac surgery
Key exclusion criteria (4 listed)
- Age < 18 years old
- Not signing written consent
- Age < 65 years old (subgroup 1)
- Emergency, aortic stenosis, main left coronary stenosis (subgroup 2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | – |
Primary outcome
renal function
4 secondary outcomes
other organ damage
prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay
sepsis
exitus
Results and safety
The study was stopped early (reason given: difficult enrollment after the primary investigator left the centre). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Landoni, MD study director
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Giuseppe Crescenzi, MD principal investigator
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2) in people with Kidney Failure and Intraoperative Complications, run by Università Vita-Salute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficult enrollment after the primary investigator left the centre). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal function. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2009; AzTrials last refreshed its copy on 6 Nov 2026.