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INTENSIVE THERAPY

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CUSTODIOL perfusion solution

Composition Active substances: 1000 ml of the solution contains 0.8766 g of sodium chloride, 0.671 g of potassium chloride, 0.8132 g of magnesium chloride hexahydrate, 27.9289 g of histidine, 3.7733 g of histidine hydrochloride monohydrate, 0.4085 g of tryptophan, 5.4651 g of mannitol, 0.00221 g of calcium chloride dihydrate, and 0.1461 g of α-ketoglutaric acid. auxiliary substances: potassium hydroxide, water for injections. Dosage formSolution for perfusion. Pharmacological group Solvents and dilution agents, including irrigation solutions. ATC code V07A B. Indications Cardioplegia during cardiac surgery. Protection of organs during surgery using ischemia (heart, kidneys, liver). Storage of organs for transplantation (heart, kidneys, liver, lungs, pancreas), including arterial and venous transplantation. Multi-organ defense. Contraindications Currently, it is unknown.

Отделения использования

Heart

solution temperature 5-8 0 C; perfusion volume 1 ml/min/g of the calculated heart mass; (For adults, the normal heart mass is approximately 0.5% of body weight, for children, approximately 0.6%); perfusion pressure (should be equal to the pressure at the aortic root): for adults, the initial pressure is 140-150 cm Hg above the heart level, which is equivalent to 100-110 mm Hg.; after heart arrest, the pressure is reduced to 50-70 cm Hg above the heart level, which is equivalent to 40-50 mm Hg. For newborns and infants, the initial pressure is 110-120 cm Hg above the heart level, which is equivalent to 80-90 mm Hg.; after heart arrest, the pressure is reduced to 40-50 cm Hg above the heart level, which is equivalent to 30-40 mm Hg. For patients with severe coronary sclerosis, the pressure is maintained slightly higher for a long period. Perfusion time: at the indicated dosage and pressure, the perfusion time is approximately 6-8 minutes. To ensure balance outside

Kidneys

The solution temperature is 5-8°C. Perfusion volume is 1.5 ml/min/g of the calculated kidney weight (normal adult kidney weight is approximately 150g). Perfusion pressure (renal artery): 120-140 cm water column above the kidney level, which is equivalent to 90-110 mm Hg at the end of the perfusion catheter in the renal artery. Perfusion time: at the indicated dosage and pressure, the perfusion time is approximately 8-10 minutes. This time is necessary to ensure the balance of the extracellular space of the kidney (including the interstitial tissue and the system of renal tubules). This time cannot be shortened. Additional measures: to ensure optimal use of the protective properties of the kidney preparation, it is important to ensure intensive diuresis before the start of perfusion (pharmacological measures and/or patient hydration). Methods of perfusion: hydrostatic perfusion with control of time and height above the kidney level or perfusion using a perfusion pump with control of time and pressure at the end of the perfusion to

Liver

Temperature of the solution 0-4 0 C Perfusion volume: if it is necessary to store the liver, pancreas and kidneys together (as one block) in an organ donor, the required perfusion volume of the product is 150-200 ml / kg body weight. For such general protection, this is equivalent to a perfusion volume of 8-12 L of refrigerated product for a patient weighing 70-80 kg. Perfusion pressure: perfusion under hydrostatic pressure is used (the container is placed at a height of 1 m above the heart level). Perfusion time: at the specified dosage and pressure, the perfusion time is about 10-15 min, but in any case not less than 8 min. Additional measures: in the organ donor, the blood must be completely heparinized before perfusion. Perfusion method: the product is introduced into the renal aorta or iliac artery of the organ donor through a suitably prepared perfusion tube (the system is emptied of air). Simultaneously with the start of perfusion, the surgeon opens the vena cava of the patient's abdominal cavity. This will allow the solution to flow out without obstruction. The entire volume of the solution is administered through the abdominal aorta, thus including all abdominal organs in the protection. The bile ducts (in the middle or outside the body) must be thoroughly flushed with at least 100 ml of the cooled product using a small-gauge catheter. If only the liver or part of the liver (e.g. in the case of a living donor) is to be removed without any other organs, the perfusion volume should be reduced accordingly. The perfusion time cannot be less than 8 min and is usually 10-15 min. In the latter case, it is necessary to ensure adequate perfusion for the arterial and portal venous circulation. Transplantation: if the organ has to be transported for transplantation, after removal, the liver is placed in a container with the cooled preparation. The organ should be completely immersed in cooled Custodiol. There is a general recommendation that the ischemia time should not exceed 12-15 hours under normal conditions. If the liver is to function in place of the removed organ (for example, for tumor enucleation), it must be kept in a refrigerated preparation throughout the procedure. Immediately after the completion of the so-called "tabletop procedure," the liver is autotransplanted.

Vein and/or artery transplantation

The vein graft (usually part of the great saphenous vein) or artery (usually part of the internal mammary artery) is cooled and stored in a chilled preparation solution (about 50-100 ml) at 5-8 °C. After removal from the solution, the vein or artery parts are immediately implanted.

Multi-organ protection

The basic technical steps of perfusion are now largely standardized and described in the relevant surgical guidelines. In terms of technical steps of perfusion, atmospheric pressure perfusion is most commonly used worldwide, using perfusion systems of the largest possible size. Even at low temperatures, Custodiol has an exceptionally low viscosity. This allows large volumes to be administered at low pressure and at low temperatures, which is required for perfusion. Multi-organ protection with Custodiol is not limited by the perfusion volume, but is based on a minimum perfusion time of 8-10 min. This means that by administering large volumes of cooled Custodiol (0-4 °C), effective cooling can be quickly achieved, thus ensuring long-term organ protection.

Transportation of donor organ

Technical measures for ensuring hypodermic storage are individual in each medical institution, and the “triple bag technique” is currently widely used in all countries. The organ removed from the donor is usually transported to the recipient in a specially designed sterile bag depending on its size (heart/kidneys), in which the organs are in ice-cold perfusion solution of the drug. The organs must be completely covered with the solution. The bag is tightly closed with adhesive tape or other similar device and placed in another container, also filled with perfusion solutions Custodiol, in order to avoid any damage to the insulating material or air ingress. The organ, provided with the protection of the double package, is placed in a sterile plastic container and tightly closed with a lid. This container is placed inside a transport box filled with ice. Information about the donor, copies of laboratory reports and donor blood samples are always included. Transportation of the donor organ in the perfusion solution of the drug should be as fast as possible.

Характеристики

Basic physical and chemical properties: transparent solution of pale yellow color
Incompatibility: Unknown
Storage conditions: Store in a dark place at a temperature of 2 0 C to 8 0 C. Keep out of reach of children.
Package: 500 ml in glass bottles, 1 l, 2 l, 5 l in bags
Vacation category: By prescription. For use in hospital settings.
Expiration date: 1 year. Do not use after expiration date.
Manufacturer: D.R. FRANZ KOHLER CHEMIE GMBH Werner-von-Siemens-Str. 14-28, D-64625 Bensheim, Germany