Universal cardioplegic solution (variants)

Abstract

This invention relates to medicine, more specifically, to cardiac surgery, and may be used for protecting the heart from ischemia when administering cardioplegia in normothermia or hypothermia. The general-purpose cardioplegic solution contains pharmaceutically acceptable potassium ions; magnesium ions; a base and an acid providing a pH buffer in a range of 7.1-8.9; a diuretic providing osmolality in a range of 275-460 mOsmol/kg. Said solution is used for cardiac protection in cardiopulmonary bypass, as well as for achieving asystole and maintaining the achieved asystole. The procedure for administering the general-purpose cardioplegic solution involves maintaining the achieved asystole by decreasing the flow rate of starting components of said solution relative to the flow rate of autoblood thus decreasing the solution to autoblood ratio.

Claims

1. A cardioplegic solution without limiting the duration of cardioplegia, comprising the following pharmaceutically acceptable components: potassium chloride: 7.45 g; magnesium sulfate: 2.34 g; mannitol: 35.9 g; trometamol: 0.5 g; hydrochloric acid: 1M to attain pH 7.6-8.0; distilled water: up to 1000 ml; wherein the solution maintains asystole for more than to two and a half hours after a single injection without repeated administration.

Description

(1) The invention is illustrated by the following drawings.

(2) FIG. 1. Scheme for application of general-purpose cardioplegic solution using a heart-lung machine (HLM) roller pump.

(3) 1HLM arterial pump; 2oxygenator connector for arterial perfusion; 3oxygenator; 4oxygenator connector for coronary perfusion; 5tubing line for coronary blood perfusion; 6pump for coronary blood perfusion; 7T-joint for stock solution and blood, 8vial with stock solution; 9HLM pump for feeding stock solution; 10tubing line for coronary perfusion of stock solution.

(4) FIG. 2. Scheme for application of general-purpose cardioplegic solution, wherein potassium chloride content is changed during surgery using a syringe dispenser.

(5) 1HLM arterial pump; 2oxygenator connector for arterial perfusion; 3oxygenator; 4oxygenator connector for coronary perfusion; 5tubing line for coronary blood perfusion; 6pump for coronary blood perfusion; 7T-joint for stock solution and blood, 8vial with stock solution; 9HLM pump for feeding stock solution; 10tubing line for coronary perfusion of stock solution; 11syringe dispenser with potassium chloride solution.

(6) FIG. 3. Scheme for application of general-purpose cardioplegic solution using a syringe dispenser.

(7) 1oxygenator; 2syringe dispenser with stock solution; 3oxygenator connector for arterial perfusion; 4oxygenator connector for coronary perfusion; 5HLM arterial pump; 6HLM pump for coronary perfusion; 7tubing line for coronary blood perfusion.

(8) Examples below illustrate but do not limit this invention.

EXAMPLE 1

(9) Delivery of general-purpose cardioplegic solution (GPCS) using a HLM roller pump (FIG. 1). This is the most universal scheme. Here, GPCS components are as follows:

(10) Potassium chloride: 8.38 g;

(11) Magnesium sulfate: 2.34 g;

(12) Trometamol: 0.5 g;

(13) Mannitol: 35.9 g;

(14) Hydrochloric acid: 1M to attain pH=7.9;

(15) Distilled water: up to 1000 ml.

(16) Osmolality is 440 mOsmol/kg.

(17) After the beginning of surgery and connection of the patient to a heart-lung machine, perfusion is performed at a body and heart temperature maintained within 25-37 C. (the optimum temperature is 36-37 C.). After puncturing the aorta with a cardioplegic cannula, the stock solution is continuously mixed with autoblood from the oxygenator at a ratio of 1:4. To perform cardiac arrest, GPCS is infused into the aortic root or directly into the coronary ostia, while maintaining infusion pressure in the aortic root at max 100 mm Hg. Following aortic cross clamping, GPCS is infused into the heart for 5 minutes to reach a stable cardiac arrest. The rate of GPCS infusion varies from 200 to 350 mL/min. To maintain the asystole, GPCS is infused into the aortic root or directly into the coronary ostia, while maintaining infusion pressure in the aortic root at max 100 mm Hg, or into the coronary sinus, while maintaining GPCS infusion pressure at max 50 mm Hg. To maintain the asystole (, the rate of GPCS delivery is slowed down to 50-150 mL/min at a solution to blood ratio of 1:8. GPCS infusion time and volumetric flow rate parameters as well as the ratios of the stock solution and autoblood from the oxygenator are determined by the preoperative concentration of potassium in the patient's blood and the size and mass of his/her heart. Upon passing through the heart, GPCS gets into the general circulation. After the intracardiac phase of surgery is completed, the GPCS delivery is stopped.

EXAMPLE 2

(18) GPCS delivery using a HLM roller pump, wherein potassium chloride content is changed during surgery using a syringe dispenser (FIG. 2). This scheme is more preferable in cardiovascular pathologies, when it is desirable to keep the rate of cardioplegic mixture perfusion at a constant level. Here, GPCS components are as follows:

(19) Potassium chloride: 3.0 g;

(20) Magnesium sulfate: 2.1 g;

(21) Trometamol: 0.2 g;

(22) Mannitol: 30.0 g;

(23) Acetic acid: 1M to attain pH=7.1;

(24) Distilled water: up to 1000 ml.

(25) The syringe dispenser is filled with a 30% potassium chloride solution.

(26) After the beginning of surgery and connection of the patient to a heart-lung machine, perfusion is performed with keeping the temperatures of the body and the heart within 25-37 C. (the optimum temperature is 36-37 C.). After puncturing the aorta with a cardioplegic cannula, the stock solution is continuously mixed with autoblood from the oxygenator at a ratio of 1:5. GPCS is infused into the aortic root or directly into the coronary ostia, while maintaining infusion pressure in the aortic root at max 100 mm Hg. The rate of potassium chloride flow from the syringe dispenser is adjusted such that the concentration in the cardioplegic line is 8.0 g/L. On achieving asystole, along with GPCS infusion, the solution from the syringe dispenser is fed for 5 minutes to reach a stable cardiac arrest. In maintaining the asystole, the delivery of the solution from the syringe dispenser is stopped while that of GPCS continues. The delivery of GPCS can be interrupted for cleaning the surgical site for up to 20 minutes. If the heart activity is suddenly resumed, along with GPCS infusion, potassium chloride solution is fed from the syringe dispenser until a complete cardiac arrest is reached. Upon passing through the heart, GPCS gets into the general circulation. After the intracardiac phase of surgery is completed, the GPCS delivery is stopped.

EXAMPLE 3

(27) GPCS infusion using a syringe dispenser (FIG. 3). This scheme is more preferable in pediatric surgery and hemodynamically significant pathologies of myocardial vasculature or when hemodilution is undesirable. Here, GPCS components are as follows:

(28) Potassium chloride: 15.0 g;

(29) Magnesium sulfate: 2.5 g;

(30) Trometamol: 1.0 g;

(31) Mannitol: 40.0 g;

(32) Citric acid: 1M to attain pH=8.9;

(33) Distilled water: up to 1000 ml.

(34) After the beginning of surgery and connection of the patient to a heart-lung machine, GPCS perfusion is performed with keeping the temperatures of the body and the heart within 25-37 C. (the optimum temperature is 36-37 C.). After puncturing the aorta with a cardioplegic cannula, GPCS fed by an electronic syringe dispenser and oxygenated autoblood fed by an HLM roller pump are mixed in a ratio of 1:4. To perform cardiac arrest, GPCS is infused into the aortic root or directly into the coronary ostia, while infusion pressure in the aortic root is maintained at max 100 mm Hg. The initial infusion of GPCS is made within 3-4 minutes after aortic cross clamping and then for another minute after cardiac arrest to ensure a stable asystole. Depending on the preoperative concentration of potassium in the patient's blood and the size and mass of his/her heart, the volumetric rate of stock solution flow from the syringe dispenser varies from 40 to 70 mL/min and the rate of autoblood flow from the HLM oxygenator varies from 160 to 280 mL/min. Upon achieving a stable asystole, the GPCS volumetric flow rate is decreased. The objective of this phase is to maintain the asystole in a stable state. To this end, the volumetric rate of stock solution delivery from the dosage syringe dispenser is slowed down to 6-17 mL/min, while the volumetric flow rate of oxygenated autoblood fed from the HLM roller pump in a ratio from 1:8 to 1:10 is simultaneously decreased to 48-136 mL/min. GPCS infusion time and volumetric flow rate parameters as well as the ratios of the stock solution and autoblood from the oxygenator are determined by the preoperative concentration of potassium in the patient's blood and the size and mass of his/her heart. To maintain the asystole, GPCS is infused into the aortic root or directly into the coronary ostia, with infusion pressure in the aortic root maintained at max 100 mm Hg, or into the coronary sinus, with GPCS infusion pressure maintained at max 50 mm Hg.

INDUSTRIAL APPLICABILITY

(35) This invention can be applied in human and veterinary medicine.