Composition, form of production and packaging
Perfusion Solution 1L
L-Histidine 27.9289 g
L-histidine chloride monohydrate 3.7733 g
L-tryptophan 408.5 mg
potassium chloride 671 mg
calcium chloride dihydrate 2.2 mg
potassium ketoglutarate 184.2 mg
magnesium chloride hexahydrate 813.2 mg
mannitol 5.4651 g
sodium chloride 876.6 mg
500 ml - bottles (10) - cardboard boxes.
1 l - polyethylene bags (6) - cardboard boxes.
2 l - polyethylene bags (4) - cardboard boxes.
5 l - polyethylene bags (2) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
Cardioplegic solution. It allows to provide effective protection of the heart in conditions of general moderate hypothermia during cardiac ischemia lasting up to 180 min after single administration. Custodiol contains histidine buffer, which allows not to resort to peroxygenation. Hyponodium buffer determines the intracellular mechanism of tissue protection. The use of CUSTODYOL makes it possible to increase the stability of the tissues of the myocardium, kidneys, and liver of other internal organs to hypoxia due to the presence in its composition of the balanced components that cause the metabolic protection of cells and their ion balance.
- protection of organs (heart, liver, kidneys, lungs) during transplantation, transportation and transplantation from the donor to the recipient;
- Protection of a venous graft (mainly a large vein vein) when replacing coronary vessels.
A heart. In adults, the solution, cooled to 5-8 В° C, is administered under hydrostatic pressure of about 100 mm Hg. (a bottle with a solution is placed at a height of 140 cm above the heart) or by a pump with a constant feed rate and perfused through the coronary arteries. During the first minute from the beginning of perfusion, the heart is stopped and then the pressure is reduced to 40-50 mm Hg. (the bottle is lowered to 50-70 cm above the level of the heart). If there is a significant stenosis of the coronary vessels, the pressure at the upper boundary of the interval (ie, about 50 mm Hg) is recommended. The total perfusion time is determined by the need for equilibration in the system and is 6-8 minutes.
In children, the heart is also perfused for 6-8 minutes at a perfusion pressure of 40-50 mm Hg. and a solution delivery rate of 1 ml / min / g of heart mass.
The kidney is perfused at a perfusion pressure of no higher than 120 mm Hg.
The liver . The solution consumption should be about 20 liters (at the rate of 300 ml per 1 kg of body weight of the donor) per 1 transplant with a duration of perfusion of about 10 min through the cannula with an internal diameter of 5 mm.
Venous transplant (usually part of a large vein vein) is placed in a solution of CUSTODOL (50-100 ml) cooled to 5-8 В° C and stored in it. Implant after extraction from solution.
Not found in the clinic or in the experiment, not noted in the literature. In the event of a possible drug exposure to the general circulatory system, the changes in the concentration of sodium and calcium ions are insignificant. If the analysis data on the content of sodium and calcium ions in the extracorporeal circulation confirm their deficiency, both electrolytes must be replenished.
Currently not known. The drug is not intended for any type of injection or infusion.
- a set for perfusion with a tee for two bottles and a perfusion tube of the required length and an inner diameter of at least 5 mm.
- Perfusion cannulae (internal diameter from 2.5 to 6 mm)
- tube clamps
- perfusion stand up to 200 cm, adjustable in height, equipped with a measuring ruler.
- refrigeration unit (provides solution cooling to 5-8 degrees Celsius).
The heart's tolerance to ischemia is determined both by perfect perfusion management from the very beginning of its carrying out, and by the temperature of the myocardium, the temperature in the area of вЂ‹вЂ‹extracorporeal circulation, the existing heart lesions, and so on. In general, under conditions of moderate systemic hypothermia (27-29 В° C), a 180-minute clotting of the aorta is well tolerated by the heart without additional cooling, but provided that the stage of recovery measures does not exceed 20 min.
Upon detection during the period of artificial cardiac arrest, atrial or ventricular activity perfusion of an additional amount of CUSTODYOL, cooled to 5-8 В° C, is performed under the same conditions. It should be remembered that the achievement of this duration of myocardial protection assumes an effective temperature equalization across the sites of the myocardium, as well as the maximum equilibrium filling of the intracellular and intercellular space of the myocardium with the solution of CUSTODOL.
The beginning of cardioplegia. After connecting the heart-lung machine, a pouch or U-shaped suture (PDS 4-0) with a loop is attached at the highest point of the ascending aorta to strengthen the perfusion cannula and the ventilation drainage. The solution should be removed from the refrigerator immediately before use to avoid the heating of the liquid under the influence of the environment. Saturation of the solution with pure oxygen or a mixture of oxygen and carbon dioxide is not required, moreover, it can have a negative effect. The solution contains a sufficient amount of oxygen (0.6% by volume) necessary to meet the needs of a stopped heart in cardioplegia (temperature 10 В° C, perfusion rate 0.2 ml / min / 100 g of heart mass). When connecting the perfusion system to a container with a cardioplegic solution, care must be taken to carefully ventilate the hose system: the air bubble trap in the system must be filled to capacity with a solution to prevent the formation of air microbubbles due to high head pressure. Immediately before the aorta is clamped, a puncture is made-an incision between the legs of the U-shaped seam and a perfusion cannula attached to the perfusion hose is inserted, and then the throttle is tightened.
After clamping the aorta, the cardioplegic solution, cooled to 5-8 В° C, with full shunting under hydrostatic pressure (the height of the perfusion capacity above the heart level is initially about 140 cm = 100 mmHg) is perfused into the root of the aorta and the coronary system. High perfusion pressure is required for:
a) guarantee of perfect closure of aortic valves;
b) achieving rapid leaching of blood from the coronary system and, as a result, rapid cardiac arrest;
c) rapid cooling of the heart and, thanks to this, additional protection of the heart from the primary lack of oxygen. After 20-40 seconds after the beginning of perfusion, the heart stops contracting.
In order not to expose an inoperable heart to the danger of excessively high perfusion pressure, the vessel with cardiovascular solution after cardiac arrest should be lowered to 50-70 cm above the level of the heart.
In severe coronary stenoses, a higher perfusion pressure (about 70 cm from the level of the vessel to the level of the heart) is required. The total duration of the cardioplegic solution should be 6-8 minutes, which is sufficient to ensure a homogeneous distribution and balance of the solution. With the beginning of the solution supply, the right atrium is opened at the cannulation site and the perfusate is aspirated through an additional cannula inserted into the upper vena cava. In the event that a significant amount of cardioplegic solution nevertheless enters the heart-lung machine, a calcium salt solution is introduced into the circulating flow to prevent the resulting blood pressure decrease.
Clinical experience shows that on small-sized hearts (children, newborns) CUSTODOL, used in the conditions described above, provides the same efficiency of functional protection as in adults. The total duration of perfusion here should also be at least 6-8 minutes at a hydrostatic pressure of 40-50 mm Hg. Art. The preferred solution delivery rate is 1 ml / min / g of heart mass.
The end of cardioplegia. Cardioplegia ends with the opening of the aorta after the coronary system is connected to the circulatory system. Very weak myocardium is recommended to perfuse with low blood pressure (about 2 minutes with an average blood pressure of 40 mm Hg). The perfusion pressure can then be normalized as the activity of the myocardium increases. Often the activity of the myocardium is restored spontaneously. If this does not happen, a single defibrillation is sufficient."Reanimation" of the heart should be carried out with a balanced acid-base state, normal concentrations in the blood of sodium, potassium and calcium ions (especially with normal concentration of calcium ions) and at a heart temperature of 32-36 В° C. Lower temperatures lead to increased fibrillation, whereas higher temperatures worsen myocardial repair due to excess inflow of energy to it.
Tolerance of the kidney to ischemia. The kidney can be stored in a cold solution of the drug (at 2-4 В° C) up to 48 h (the so-called cold ischemia time). The time of warm ischemia, by which is meant the time necessary for complete anastomosis of the vessels, is usually 30 min. In view of this time interval, it is considered that a complete restoration of the organ functions is possible, if no more than 24 hours have elapsed from the moment of engraftment. From the point of view of both theory and practice in operations in situ this time is sufficient. Thus, when using CUSTODYOL, the preservation of the kidney from the point of view of ischemic lesions increases by 2-3 times.
The beginning of a kidney transplant. If the laparotomy was successful, the kidney is prepared by applying a ligature to the capsule vessels. A catheter for selective perfusion is fixed in the renal artery using a turnstile. The perfusion is carried out under hydrostatic pressure. On the first minute of perfusion, the renal vein is cut and pressed against the hollow vein. The resulting perfusate is aspirated from the abdominal cavity. Perfusion for about 10 minutes. If further transplantation is to be performed, resection is performed if the tumor is excised and the kidney is left in place.
Tolerance of the liver to ischemia. According to the literature, the liver, transplanted 21 hours after ischemia, functions normally. However, it is also known that at times of conservation of more than 12 hours, the rates of so-called primary disorders may increase. At the same time, it can be argued that, with liver protection with CUSTODOL, the number of disorders in the form of bile anastomoses occurs within 12 hours.
The beginning of a liver transplant. Usually, the Fence Center decides whether to perform liver perfusion in situ with subsequent preparation or vice versa.Standardized data on the conditions of application of Custadiol are not yet available. As a recommendation, perfusion of about 20 liters of the drug, cooled to 5-8 В° C (at the rate of 300 ml per kg of body weight of the donor) can be suggested. If the Fence Center decided to perform aortic perfusion - the collar vein, there is no need for either a pressure pump or a separate aortic line. All trumpet pipes should have the largest possible diameter. This also applies to the cannula, which must have an internal diameter of at least 5 mm. In these conditions, it is sufficient to perfuse the organ within 10 minutes. If the whole solution is intended to be delivered through the aorta, it is necessary to use a system with a tee, a tube and a cannula with a maximum large internal diameter (not less than 5 mm). The solution goes, as in the previous version, by gravity, and it is recommended to perform liver decompression before the beginning of perfusion.
Transportation of donor organs. The transportation of organs (heart, kidneys, lungs) from the donor to the recipient is carried out in special bags suitable for the size in which they are filled with the drug at a temperature of about 0 В° C. The organ must be completely covered with a solution. The bag is glued with adhesive tape and placed in a second bag, also filled with a cold preparation (in case of damage to the 1st bag and to improve thermostating). The organ in a double bag is placed in a sterile plastic transport container filled with ice. Attach information about the donor, copies of the results of laboratory tests and blood samples. Delivery of the organ to the place of use should be carried out as soon as possible.
In the event of the possible entry of CUSTODOL in the general circulatory system, changes in the concentration of sodium and calcium are insignificant. If the analysis data on sodium and calcium in the extracorporeal circulation confirm their deficiency, both electrolytes must be replenished.
Reports of any interactions with pharmaceuticals such as glycosides, diuretics, nitrates, antihypertensives, calcium antagonists, beta blockers used in the preoperative period are not available.
TERMS AND CONDITIONS OF STORAGE
Storage conditions : Store at a temperature of 8-15 В° C in places protected from light and not accessible to children!
Apply within the time limit stated on the package!
Shelf life : Shelf life is 1 year and is indicated on the package.
Do not use after the expiration date indicated!