User application: hemosorbent «LPS-НЕМО»
«LPS-НЕМО» is an biospecific lipopolysaccharide hemosorbent, polymer matrix with immobilized ligand in it- antibiotic Polymyxin (Polymyxin B, Polymyxin E/Colistin, Polymyxin M), which is packed in a mass exchange module for a single application hemosorption (MMH), filled with a solution of sodium chloride 0,9% for injections, placed in a polyethylene package and sterilized. Its purpose is detoxification of the body in septic conditions, especially in the case of endotoxic shock, by selective removal of lipopolysaccharide nature sensitinogens (endotoxin, LPS), formed and accumulated in the tissues invaded by predominantly gram negative microorganisms: Colibacillus, Pseudomonas aeruginosa, Klebsiella, Salmonella typhi, Salmonella paratyphi, etc. Biospecific ligand Polymyxin selectively links LPS by connection with its lipid part (lipid A) and blocks active chemical groups, wherein LPS structure dissociates irreversibly. Hemosorbent «LPS-НЕМО» has high bio- and hemocompatibility (thromboresistance, absence of dust particles, low nonspecific sorption of plasma proteins), which provides good hemodynamic and kinetic of the sorption detoxification process.
2. The main characteristics of hemosorbent «LPS-НЕМО»
Biospecific polyacrylamide hydrogel is not soluble in a water. The chemical composition of biospecific hemosorbent: - Polymyxin В (E, M) - 2,0-2,5 mg / ml;
- polymer matrix-10% - 90% by weight
- coupling agent - 1% by weight
Biospecific hemosorbent in an isotonic sodium chloride solution 0,9% for injections is formed as fibers and light gray granules with a diameter 0.5-5,0 mm. Ph of the isotonic sodium chloride solution 0,9% for injections, which fills MMH with biospecific hemosorbent, is 5,0-7,0.
Specific capacity for endotoxin E.coli 0113 («Sigma», Germany) or E.coli 0157:H7 (Research Institute of Epidemiology and Microbiology, Belarus)- not less than 0,5 mkg/ml of hydrogel. Hemosorbent «LPS-НЕМО» is produced as MMH for a single application
hemosorption 100 ml capacity, there are 25-45 ml of biospecific hemosorbent in every MMH. Hemosorption impact on the amount of blood cells in processing of 1,0 BCC
with preliminary administration of heparin in a dose of 1 mg / kg body weight:
- decrease in the number of platelets- not more than 10-15%
- decrease in the number of white blood cells- not more than 5-10%
- decrease in the number of red blood cells- not more than 5-10%
Hemosorbent «LPS-НЕМО» is subjected to radiation sterilization in a dose 2.5 Mrad at dose rates of 1 Mrad / hr.
3. The safety requirements
MMH use in the process of sorption requires compliance of the work rules with conditionally pathogenic material (Decree № 47 of the Ministry of Health of the Republic of Belarus from 28.04.2010).
Hemosorption using hemosorbent "LPS-hemo" is carried out in accordance with the procedure of hemosorption according to the guidelines of the Republic of Belarus approved by the Ministry of Health as an official document 14.07.1999 "Extra- and intracorporeal methods of hemostasis correction in clinical practice".
4. Using the hemosorbent
4.1. Preparation of the hemosorbent. Before hemoperfusion MMH with hemosorbent are washed quintuply by sterile isotonic sodium chloride solution 0,9% for injections. Recommended flow direction is top to bottom. The solution is drained from the column by replacing it with blood. The connection of the extracorporeal circuit is carried out under aseptic and antiseptic conditions. Before hemosorption external inspection are carried out to verify compliance of label indicator, integrity of the module.
Parameters of hemosorption:
- time of perfusion through one MMH- 60-180 minutes
- perfusion rate from 5-10 to 100 ml/min which depends on body weight and blood circulation capasity (BCC)
- total volume perfusion- not less than 1,0 BCC
4.2. Training before sorption - defining moment of hemosorption and it must be direct on adequate correction of functional blood, macro- and microhemodynamics systems. For this purpose it is recommended to fill BCC, to hold measures of hemodilution creation (reduction of hematocrit to 33%), to improve blood rheology (introduction of disaggregants and rheological correctors: Trentalum-1,0-3,0 mg/kg body weight, Neorondeks/ Mikrodez/Reopolyglukine-10-20 ml/kg body weight, etc.), to eliminate electrolyte imbalance.
For increasing of the organism antithrombin potential when hemosorbent is used in patients with hepatic insufficiency of any genesis it is necessary to transfuse the same group fresh frozen plasma (3-5 ml/kg body weight).
5. The indications for use
5.1. Hemosorbent «LPS-НЕМО» can be used for the purpose of organism detoxification in every pathological conditions, which are accompanied by bacterial aggression:
- sepsis;
- pyoperitonitis;
- meningitis;
- wide necrotic processes of soft tissues;
- hypotension caused by shock of bacteremia;
- pneumonia;
- burn disease, complicated by a bacterial infection;
- urinary infection
6. Contraindications
6.1. Hemosorbent «LPS-НЕМО» absolutely contraindicated in case of:
- agonal state;
- continued bleeding
6.2. Hemosorbent «LPS-НЕМО» relative contraindicated in case of:
- the presence of potential sources of bleeding (erosive gastritis, unhealed ulcer, ulcerative colitis);
- hypotension caused by hypovolemia or cardiac weakness is temporary contraindication and after replenishment of BCC shortage and compensation of cardiac activity it can be considered secure.
7. Side effects
Hemosorbent «LPS-НЕМО» has no allergic, general toxic effect on the body, matches toxicological standards for medical devices that contacts with blood.
8. Clinical and laboratory evaluation of the effectiveness
8.1. General condition of the patient.
8.2. Hemodynamics during the procedure and on the following day (heart rate, systolic and diastolic blood pressure, average blood pressure).
8.3. Complete blood count (erythrocytes, leukocytes, platelets, blood count, ESR, indicators of secondary hemostasis (APTT, prothrombin time, thrombin time)- not earlier than 10-12 hours after last injection of heparin for exclusion of the anticoagulants effect on the morphological composition and clotting ability of the blood.
8.4. Markers of protein metabolism (total protein, albumin, fibrinogen, «middle molecules», urea, creatinine, ALT, AST). Proteolytic activity, level of the kallikrein-kinin system components, inhibitory potential of the plasma before and after hemosorption.
9. Packing, marking, transportation, storage:
9.1. Hemosorbent «LPS-НЕМО» is available as a MMH, comprising 25-45 ml of hemosorbent and is packed in cartons.
9.2. Storage - heated storage room.
9.3. Transportation with any kind of covered transport at a temperature from 4°C to 25°C.
9.4. Expiration date - 3 years.
9.5. Marking- label on each box and MMH. Label indicates: manufacturer, product name in Russian and Latin, dose volume, sterility, storage conditions, series number, expiration date, registration number of specifications.
9.6. Compliance with instructions for hemosorbent «LPS-НЕМО» use ensure its indicators and safety for the patient.
9.7. Using hemosorbent "LPS-Hemo" together with other sorbents SP ALC "Farmavit" is possible only by the decision of the attending physician.