A multicentre randomised placebo-controlled double-blind study on adjuvant treatment of mediastinitis with immunoglobulins (Pentaglobin) after cardiac surgery (ATMI): outline and preliminary study protocol for discussion. The ATMI Study Group.

Abstract

We present the second draft of a consensus-assisted protocol on the adjuvant treatment after cardiac surgery with immunoglobulins of mediastinitis. CLINICAL PHASE: Phase III.

OBJECTIVE OF THE STUDY:

Placebo-controlled investigation of the clinical efficacy of Pentaglobin (Biotest, Germany) as an added treatment in patients with mediastinitis.

MEDICATION:

Group A, active Pentaglobin; Group B, placebo: 5% glucose solution with 1% human albumin.

DOSAGE:

5 ml/kg body weight Pentaglobulin or placebo intravenously each day for 5 days.

STUDY DESIGN:

Prospective, placebo-controlled, double blind, randomised, multicentre.

SAMPLE SIZE:

n = 100; 50 patients with Pentaglobin (active), 50 patients with placebo.

PRIMARY OUTCOME MEASURE:

Cumulative therapeutic intervention scoring system (TISS-28) during hospital stay.

• Authors: G Marggraf, E A Neugebauer
• Journal: The European journal of surgery. Supplement. : = Acta chirurgica. Supplement (Eur J Surg Suppl) Issue 584 Pg. 26-32 ( 1999) ISSN: 1102-416X [Print] England
• PMID: 10890228 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Immunoglobulin A
• Immunoglobulin M
• Immunoglobulins, Intravenous
• Placebos
• pentaglobulin

Topics

• Anti-Bacterial Agents (therapeutic use)
• Cardiac Surgical Procedures (adverse effects)
• Double-Blind Method
• Follow-Up Studies
• Humans
• Immunoglobulin A (therapeutic use)
• Immunoglobulin M (therapeutic use)
• Immunoglobulins, Intravenous (therapeutic use)
• Mediastinitis (therapy)
• Patient Selection
• Placebos
• Prospective Studies
• Research Design
• Sample Size
• Sepsis (therapy)
• Surgical Wound Dehiscence (therapy)
• Surgical Wound Infection (therapy)
• Treatment Outcome