Study of Albumin to Reduce Inflammation Following Surgery

NCT00773110 | Terminated Phase 2 DMC

• 2 other identifiers: CRO888DHTCA_P09889
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Inflammatory Response Syndrome; Cardiopulmonary Bypass

Keywords

hemolysis; systemic inflammatory response syndrome; cardiopulmonary bypass; albumin

Outcome Measures

Primary Outcomes (1)

• Time from surgery to intensive care unit discharge

  Hourly

Secondary Outcomes (4)

• Degree of hemolysis - free hemoglobin and haptoglobin

  Prior to and at 0, 2, 6 and 24 hours after CPB

• Haematological and physiological markers of the inflammatory response - Temperature, pulse rate, respiratory rate, white cell count and C-reactive protein

  At regular intervals following CPB until intensive care unit discharge

• Biochemical and physiological markers of organ dysfunction

  At regular intervals following CPB until intensive care unit discharge

• Haematological markers of the inflammatory response

  Prior to and at 0, 2, 6 and 24 hours after CPB

Study Arms (2)

1 Albumin

EXPERIMENTAL

Priming of the cardiopulmonary bypass circuit with 20% human albumin solution prior to surgery

Drug: 20% Human albumin solution

2 Gelofusin

PLACEBO COMPARATOR

Priming of the cardiopulmonary bypass circuit with gelofusin prior to surgery

Drug: Gelofusin

Interventions

20% Human albumin solution DRUG

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)

Also known as: Zenalb injection

1 Albumin

Gelofusin DRUG

Priming of the cardiopulmonary bypass circuit with Hartmann's solution (1000 mL), Gelofusine (300 mL, 4% succinylated gelatin, a synthetic colloid) and heparin (10,000 IU)

2 Gelofusin

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over sixteen years of age undergoing surgery that requires cardiopulmonary bypass who provide informed written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Adult Intensive Care Unit, Royal Brompton and Harefield NHS Trust

London, London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Hemolysis

Interventions

succinylated gelatin

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Mark J Griffiths

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 28, 2014

Record last verified: 2010-05

Locations

GB (1)