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


METHODS
Group A, active Pentaglobin; Group B, placebo: 5% glucose solution with 1% human albumin.
5 ml/kg body weight Pentaglobulin or placebo intravenously each day for 5 days.


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


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


METHODS
Cumulative therapeutic intervention scoring system (TISS-28) during hospital stay.
Marggraf
G
G
II. Dept. of Surgery, University of Cologne, Germany.
Neugebauer
E A
EA
D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D007070:Immunoglobulin A / Q000627:therapeutic use*; D007075:Immunoglobulin M / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D008480:Mediastinitis / Q000628:therapy*; D018579:Patient Selection; D010919:Placebos; D011446:Prospective Studies; D012107:Research Design; D018401:Sample Size; D018805:Sepsis / Q000628:therapy; D013529:Surgical Wound Dehiscence / Q000628:therapy; D013530:Surgical Wound Infection / Q000628:therapy; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D007070:Immunoglobulin A; D007075:Immunoglobulin M; D016756:Immunoglobulins, Intravenous; D010919:Placebos; C060166:pentaglobulin