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
G. Marggraf et Eam. Neugebauer, 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, EURO J SURG, 163, 1999, pp. 26-32
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.