For data management and neither calculations we used Excel 2011 and Stata 11.0 for Mac (Stata Corporation, College Station, TX, USA). A two-sided P-value ��0.05 was generally considered statistically significant.Ethical approvalThe study was approved by the Ethics Committee of the Medical University of Vienna. According to Austrian law and the guidelines of the research ethics committee, written informed consent was obtained from patients after they regained consciousness.ResultsA total of 38 critically ill patients with MOF, a SIRS/sepsis diagnosis and clinical signs of CIPNM were recruited between December 2004 and April 2009 and randomized to either receive IVIG or placebo (Figure 2). The study team determined during the first interim analysis that the trial be terminated due to futility in reaching the primary endpoint.

This decision was based on similar CIPNM scores in the intervention and control group after enrollment of 38 patients. Nineteen patients were treated with IVIG and 19 with placebo for three consecutive days, respectively. Treatment was started at a median five (three to seven) days after the onset of SIRS/sepsis. There were no significant differences in baseline characteristics between the two study groups. CIP, CIM and CIPNM scores in both study groups were markedly increased on baseline confirming the signs of CIPNM found in the clinical examination (Table 1).Figure 2Screening and randomization scheme. Patients were screened for multiple (��2) organ failure and a SIRS/sepsis diagnosis. Patients meeting these criteria were assessed by a neurologist for clinical signs of critical illness polyneuropathy and/or .

..Table 1Admission reason and patients�� characteristicsThe primary outcome CIPNM severity sum score on Day 14, as assessed by a combination of EPS of the ulnar, median and tibial nerves and histological examination of a muscle biopsy were not statistically different between the two groups (Figure 3a).Figure 3Critical illness polyneuropathy, myopathy and critical illness polyneuropathy and/or myopathy scores. Critical illness polyneuropathy and/or myopathy (CIPNM) severity sum score was not different on Day 14 between the intravenous immunoglobulin (IVIG) …Moreover, neither isolated findings of EPS on days 0, 4, 7 and 14 (CIP score) nor of the histological examination of muscle biopsies on days 0 and 14 (CIM score) differed between the two groups on any of the time points (Figures 3a, b).

Similarly, the secondary outcomes 28-day mortality and length of ICU stay were similar between the groups (Table 1). CIPNM deteriorated significantly from Day 0 to Day 14 regardless of the group allocation (Figure 3a).At baseline, 16% of the patients (5/32) presented with increased CIP scores only, 16% (5/32) with increased CIM scores only, and 66% AV-951 (21/32) with a combination of increased CIM and CIP scores.