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Sponsors and Collaborators: |
Imperial College London J P Moulton Charitable Trust |
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Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00773110 |
The purpose of this study is to determine whether albumin adminstration during cardiac surgery is effective in attenuating the development of inflammation following surgery.
Condition | Intervention | Phase |
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Systemic Inflammatory Response Syndrome Cardiopulmonary Bypass |
Drug: 20% Human albumin solution Drug: Gelofusin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Scavenging Free Haemoglobin Attenuates the Systemic Inflammatory Response Following Surgery |
Estimated Enrollment: | 500 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 Albumin: Experimental
Priming of the cardiopulmonary bypass circuit with 20% human albumin solution prior to surgery
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Drug: 20% Human albumin solution
Priming of the cardiopulmonary bypass circuit with Hartmann's solution (1000 mL), 20% Human serum albumin(300 mL), 0.9% sodium chloride solution (200 mL) and heparin (10,000 IU)
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2 Gelofusin: Placebo Comparator
Priming of the cardiopulmonary bypass circuit with gelofusin prior to surgery
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Drug: Gelofusin
Priming of the cardiopulmonary bypass circuit with Hartmann's solution (1000 mL), Gelofusine (500 mL, 4% succinylated gelatin, a synthetic colloid) and heparin (10,000 IU)
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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 insults, including major trauma and surgical procedures, including those necessitating cardiopulmonary bypass (CPB). In this population the incidence of SIRS is high, afflicting up to 70% of patients. This may be manifest from an increased vasopressor requirement, to refractory hypotension, and multiple organ dysfunction syndrome (MODS) with liver, renal, myocardial, and neurological problems. MODS is associated with significant mortality rates of around 30-45%. Survivors require prolonged and costly intensive care, thereby representing a considerable burden for the healthcare services. Survivors often suffer considerable morbidity and have significantly impaired health related quality of life.
Despite intense investigations of anti-inflammatory therapies in SIRS and its sequelae, the case of patients is largely supportive whilst underlying triggers (such as infection) for the process are treated. Indeed, the only therapy drotrecogin alfa (activated) demonstrated to reduced mortality in a randomised study has only been investigated in patients with the most severe SIRS consequent of infection (i.e. severe sepsis) and is contra-indicated in those who have just undergone surgery.
Haemolysis is a common feature of surgery requiring CPB and may potentiate the development of SIRS and organ injury through the release of heme/iron. Furthemore, haemolysis during CPB may lead to the depletion of important mechanisms which scavenge free heme/hemoglobin from the circulation. Albumin, the most abundant plasma protein, has specific and non-specific heme and iron binding sites which are used under circumstances in which standard scavengers are overwhelmed. However, albumin is also depleted following CPB. It is therefore hypothesised that by priming the CPB circuit with albumin the heme/iron scavenging capability of the plasma will be maintained following surgery and that the systemic inflammatory response will be attenuated.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dan D Melley | +44 (0)7946419243 | dan.melley@imperial.ac.uk |
Contact: Simon J Finney | s.finney@imperial.ac.uk |
United Kingdom | |
Adult Intensive Care Unit, Royal Brompton and Harefield NHS Trust | |
London, United Kingdom, SW3 6NP |
Principal Investigator: | Mark J Griffiths | Royal Brompton Hospital NHS Trust |
Responsible Party: | Imperial College London ( Gary Roper, Research Governance Manager ) |
Study ID Numbers: | CRO888, DHTCA_P09889 |
Study First Received: | October 15, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00773110 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee |
hemolysis systemic inflammatory response syndrome cardiopulmonary bypass albumin |
Systemic Inflammatory Response Syndrome Shock Hemolysis |
Heparin Calcium heparin Inflammation |
Pathologic Processes Disease Syndrome |