The Impact of IVIG Treatment on Critical Illness Polyneuropathy and/or Myopathy in Patients With MOF and SIRS/Sepsis (CIPNM)
Polyneuropathies
About this trial
This is an interventional treatment trial for Polyneuropathies focused on measuring Critical illness, Critical illness polyneuropathy and/or myopathy, Intravenous immunoglobulins, Multiple organ failure, SIRS, Sepsis
Eligibility 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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
IgM-enriched Intravenous Immunoglobulins
Human Albumin
IgM-enriched IVIG (Pentaglobin, Biotest Pharma GmbH, Dreieich, Germany) at a dose of 0.25g/kg body weight/day as a continuous intravenous infusion at a rate of 2g/h over a period of 3 days
Human albumin 1% (Biotest Pharma GmbH, Dreieich, Germany) as placebo at a dose of 0.25g/kg body weight/day as a continuous intravenous infusion at a rate of 2g/h over a period of 3 days