Status:
TERMINATED
Study of Albumin to Reduce Inflammation Following Surgery
Lead Sponsor:
Imperial College London
Conditions:
Systemic Inflammatory Response Syndrome
Cardiopulmonary Bypass
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether albumin administration during cardiac surgery is effective in attenuating the development of inflammation following surgery.
Detailed Description
The host response to infection and other forms of tissue injury has been termed the systemic inflammatory response syndrome (SIRS). SIRS is seen in association with a wide variety of non-infective ins...
Eligibility Criteria
Inclusion
- All patients over sixteen years of age undergoing surgery that requires cardiopulmonary bypass who provide informed written consent
Exclusion
- Lack of informed consent
- Pregnancy
- Cyanotic congenital heart disease (due to high haemoglobin levels and increased haemolysis)
- Patients undergoing other extracorporeal interventions (ventricular assist devices, extracorporeal membrane oxygenators, pre-admission dialysis)
- Patients with congenital haemoglobinopathies (e.g. thalassaemia, cryoglobinuria, etc)
- Patients with disorders of iron metabolism (e.g. haemochromatosis)
- Religious objections to transfusion of a plasma-derived product
- Patients with known blood borne infection
- Patients with known hypersensitivity to gelofusine or human albumin solution
- Patients with an additive EUROSCORE of 10 or more
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00773110
Start Date
December 1 2008
End Date
May 1 2011
Last Update
May 28 2014
Active Locations (1)
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1
Adult Intensive Care Unit, Royal Brompton and Harefield NHS Trust
London, London, United Kingdom, SW3 6NP