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Study of Albumin to Reduce Inflammation Following Surgery

NCT00773110 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2014-05-28

No results posted yet for this study

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

Interventions

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)

DRUG

Gelofusin

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)

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Mark J Griffiths · Royal Brompton & Harefield NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00773110 on ClinicalTrials.gov