A multicentre randomised placebo-controlled double-blind study on adjuvanttreatment of mediastinitis with immunoglobulins (Pentaglobin((R))) after cardiac surgery (ATMI): Outline and preliminary study protocol for discussion

We present the second draft of a consensus-assisted protocol on the adjuvan t treatment after cardiac surgery with immunoglobulins of mediastinitis. Clinical phase: Phase III. Objective of the study: Placebo-controlled investigation of the clinical ef ficacy of Pentaglobin(R) (Biotest, Germany) as an added treatment in patien ts with mediastinitis. Medication. Group A, active Pentaglobin(R) Group B, placebo: 5% glucose sol ution 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, mu lticentre. Sample size: n = 100; 50 patients with Pentaglobin(R) (active), 50 patients with placebo. Primary outcome measure: Cumulative therapeutic intervention scoring system (TISS-28) during hospital stay.