Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Critically ill patients with failure of at least 2 organ systems diagnosed with SIRS or sepsis fulfilling the following inclusion criteria will be included in this study.

Age Range: 18 - 80 years
written information and consent as early as possible
Male and female patients

Clinical signs of incipient CIPNM:

decreased tendon reflexes as compared to the admission examination at the ICU
or weakness in responsive and co-operative patients as compared to the ad-mission examination at the ICU
or signs of incipient muscular atrophy as compared to the admission examination at the ICU

Organ failure:

Patients have to meet at least two of the following 5 criteria:

cardiovascular system dysfunction: arterial systolic blood pressure<90mm Hg, or mean arterial pressure < 70mm Hg for at least one hour despite adequate fluid resuscitation, adequate intravascular volume status or the use of vasopressors in an attempt to maintain a systolic blood pressure >90mm Hg or a mean arterial pressure >70mm Hg.
kidney dysfunction: Urine output < 0,5ml/kg body weight/ hour for 1 hour, despite adequate fluid resuscitation
respiratory system dysfunction: Ratio of PaO2 to FiO2 < 250 in the presence of other dysfunctional organs or systems
hematologic dysfunction: Platelet count <80.000/mm3 or decreased by 50% in the 3 days preceding enrollment (in the absence of liver cirrhosis or previously known hematological disease)
metabolic dysfunction: In case of unexplained metabolic acidosis - pH<7,30 or base deficit >5.0mmol/ litre in association with a plasma lactate level >1,5 times of the upper normal limit

SIRS:

Patients have to meet at least three of the following four criteria:

core temperature >38 or <36°C
heart rate >90 beats /min, except medical conditions known to increase heart rate
respiratory rate >20 breaths/min or a PaCO2 of <32mm Hg or the use of mechanical ventilation for an acute respiratory process
a white- cell count of>12.000 cells/mm3 or <4.000 cells/mm3 or a differential count showing >10% immature neutrophils

Sepsis:

Known or suspected infection evidenced by one or more of the following:

white cells or bacteria in a normally sterile body fluid
perforated viscus
radiographic evidence of pneumonia in the association with the production of purulent sputum
a syndrome associated with a high risk of infection

Exclusion Criteria:

The inclusion criteria have to be met at the time of enrolment into the study, i.e. at the start of the baseline period. Patients with any of the following conditions will be excluded from the study:

Age < 18 years or > 80 years
Weight >135 kg
Pregnancy or breast-feeding
Patients with known absolute IgA-deficiency with proven antibody formation against IgA
Patients with known IVIG-intolerability
Patients with known pre-existing neuromuscular disorders will not be included. Patients with documented pre-existing severe polyneuropathy will be excluded.
Patients with known diseases of the peripheral nerval system and patients with pre-existing disease of the central nerval system with relevant impairment of the motor function.
Patients with relevant pulmonary edema secondary to severe heart failure will be excluded because of the relatively high infusion volume (5ml /kg body weight per day over 3 days) determined by the study medication
Patients not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasma or other end-stage disease
Moribund state in which death is perceived to be imminent
HIV infection in association with a last known CD4 count of<50/mm3
Prediction, based on clinical judgement, that the patient will require chronic ventilatory support for non-respiratory reasons (e.g. neuromuscular disease, paraplegia