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CUSTODIOL is a brand name for Potassium Chloride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • Cardioplegia in cardiac surgery operations, • protection of organs during operations in a bloodless field (heart, kidney, liver), • preservation of organ transplants: perfusion and cold storage (heart, kidney, liver, pancreas).
Verbatim from this product's MHRA label. Tap a section to expand.
A.
Cardioplegia Perfusion volume:
The perfusion rate is 1 ml/minute/gram heart weight. 5 and 2 litres. Temperature of the solution 6°C – 10°C in open heart procedure Perfusion pressure (= pressure in the aortic root): In adults, initially 110 to 140 cm hydrostatic pressure, equivalent to 80 to 110 mmHg are used.
The surgeon has to make sure, that the aortic valve is closing properly. After onset of cardiac arrest, the pressure is reduced by half to 50 – 70 cm hydrostatic pressure, equivalent to 40 – 60 mmHg. In case of severe coronary stenosis, a higher pressure should be used (approx.
50 mmHg).
Perfusion time:
Using this dosing and pressure regimen, the perfusion time must be 6 – 8 minutes in order to achieve myocardial homogeneous equilibration and this time should not be shorter under any circumstances.
Perfusion technique:
After clamping the aorta and simultaneous “venting” of the left ventricle, the solution will be administered antegrade. Cardioplegic perfusion can be performed by either a roller pump with constant volume or by gravity (after cardiac arrest, the solution bag must be kept at 40-50 cm above the level of the heart).
Administration guidelines for additional cardioplegic perfusion:
If cardioplegic reperfusions gets necessary, perfusion time should be 1 – 2 minutes (equivalent to 200 – 400 ml); the perfusion pressure should correspond to the pressure in the last minute of the initial cardioplegic coronary perfusion.
In most cases, the patient is placed in moderate systemic hypothermia. Usually, Custodiol is given via the aortic root. In case of aortic insufficiency and of dissection of thoracic aortic surgery, the solution must be administered by selective coronary perfusion into the coronary ostia.
Due to a limited amount of clinical data a positive benefit/risk ratio for the use of Custodiol in short surgery procedures (<90 minutes) has not been confirmed yet.
Administration guidelines for retrograde perfusion on coronary sinus:
Cardiac/vascular disorders Not known (frequency cannot be estimated from the available data): Therapeutic use of Custodiol for perfusion may result in a blood pressure reduction, as storage of the solution may result in the formation of a reaction product (micimopine) from the components L-histidine and α-ketoglutaric acid, which may reduce blood pressure by blocking the angiotensin II receptors of subtype 1.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
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Only colourless to pale yellow solutions from intact containers should be used. Custodiol will be taken out of the refrigerator just before use. Not for systemic administration. Custodiol is not suitable for replenishment of circulatory volume or for replacement of amino acids or electrolytes.
As a precaution, in the event of an emergency operation on the heart during pregnancy the cardioplegic solution should be removed by suction from the right atrium and ventricle of the heart after the end of the operation. Depending on the underlying operation, the method used, the duration of the procedure and size of the patient, up to 3 l of the cardioplegic solution can enter the systemic circulation.
This can result in a fall in the serum levels of calcium and sodium. Appropriate laboratory monitoring should therefore be undertaken. Inactivation of the heart accounts for its susceptibility to distension. Thus, relaxation of the left ventricle must take place when inducing cardioplegia and is important to ensure adequate ventricular drainage.
The recommended perfusion volumes and pressures should not be exceeded. Special caution is required for the hearts of children and infants. 2. Because the sodium concentration in Custodiol is lower than in blood, administration of Custodiol may cause hyponatraemia.
It is important to note that this hyponatremia does not modify blood osmolarity because Custodiol has an osmolarity close to that of blood. Therefore, no deleterious consequences are expected in the patient from the decreased sodium level caused by Custodiol administration.
In order to mitigate the haemodilution consequences associated with the use of Custodiol in cardiac surgery, it is recommended to use hemofiltration during CEC. In case of improper permanent perfusion with insufficiently cooled cardioplegic solution (>20°C and >15 minutes), a so-called calcium paradox can be initiated, which occurs after reconnection to the circulation as destruction of the cardiac muscle cells.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Do not exceed 30 mmHg infusion pressure (usually about 250 ml/min) for a retrograde infusion of the same duration as an antegrade infusion (6-8 minutes minimum). B. Heart transplantation Following cross-clamping of the ascending aorta, the heart is perfused for at least 6 minutes.
5 litres or more for adults.
Perfusion pressure (= pressure in the aortic root):
In adults, initially 110 to 140 cm hydrostatic pressure, equivalent to 80 to 110 mmHg are used. The surgeon has to make sure, that the aortic valve is closing properly. After onset of cardiac arrest, the pressure is reduced by half to 50 – 70 cm hydrostatic pressure, equivalent to 40 – 50 mmHg.
In case of severe coronary stenosis, a higher pressure should be used (approx. 50 mmHg).
Perfusion time:
Using this dosing and pressure regimen, the perfusion time must be 6 – 8 minutes in order to achieve myocardial homogeneous equilibration and this time should not be shorter under any circumstances.
Perfusion technique:
After clamping the aorta and simultaneous “venting” of the left ventricle, the solution will be administered antegrade. Cardioplegic perfusion can be performed by either a roller pump with constant volume or by gravity (after cardiac arrest, the solution bag must be kept at 40-50 cm water column above the level of heart).
If the heart perfused with Custodiol is to be transplanted, in order to maintain protection, it must be stored and transported in cold Custodiol at 2°C – 4°C. Protection can then be reliably achieved for up to five hours. C. 5 ml Custodiol per minute and gram of estimated kidney weight (the normal weight of the kidney in an adult is approximately 150 grams).
Including 500 ml storage solution, this leads to a total volume of ca. 5 litres of Custodiol per organ. Perfusion pressure (renal artery): 120 to 140 cm water column above the level of the kidney equivalent to approximately 90 to 110 mmHg at the tip of the perfusion catheter in the renal artery.
Perfusion time:
Using this dosing and pressure regimen, the perfusion time is 8 – 10 minutes. This time is necessary in order to achieve homogeneous equilibration of the extracellular space of the kidney (including the interstitium and tubular system), and this time must not be shorter under any circumstances.
Accompanying measures:
In order to derive maximum benefit from the protective efficiency of Custodiol in the kidney, it is important to ensure pronounced diuresis prior to the start of perfusion (pharmacologically and/or hydration of the patient). Custodiol is given via the Arteria renalis.
If the kidney perfused with Custodiol is to be transplanted, in order to maintain protection it must be stored and transported in cold Custodiol at 2°C – 4°C. Protection can then be reliably achieved for 48 hours. D. Liver transplantation The following general administration guidelines can be recommended for the liver: Temperature of the solution: 5°C – 8°C Perfusion time: Using this dosing and pressure regimen, the perfusion time is 8 minutes (10-15 minutes).
Perfusion volume:
If the liver, pancreas and kidneys are to be protected all together in a so-called donor organism, a perfusion quantity of 150 – 200 ml {Invented name}/kg body weight is necessary. With this "overall protection", this is equivalent to a perfusion quantity of cold Custodiol-solution of 8 – 12 l in patients weighing approximately 70 – 80 kg.
g. in the case of live donation) is being removed without other organs, the perfused volume is reduced accordingly. Perfusion pressure: 100 cm water column above […]
e. e. no longer than 20 minutes. Immersion of a whole heart in cold Custodiol, however, does not represent a risk in the sense of a calcium paradox even when used over hours - e. g. for the time interval between removal of the organ from the donor and transplantation into a recipient.
Therefore, with proper application, a calcium paradox is virtually impossible even under extreme experimental conditions. Reversal of cardioplegia occurs by re-opening the aorta. It is advisable to initially perfuse the myocardium, which is very flaccid as a result of the cardioplegia, with a low blood pressure (mean arterial pressure of 40 mmHg for approximately 2 minutes).
As the activity of the myocardium increases, the perfusion pressure can be returned to normal. Cardiac activity frequently returns with a spontaneous rhythm, otherwise one defibrillation is generally sufficient. 0 mmol sodium per 1000 ml.
To be taken into consideration by patients on a controlled sodium diet. 0 mmol potassium per 1000 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet. This solution is not intended for use with a continuous perfusion machine.