CUSTODIOL-HTK SOLUTION

The Organ Transplant Solution

HTK (Histidine-Tryptophan-Ketoglutarate) Solution is used by Leading Transplant Centers worldwide for the preservation of the Kidney, Liver, Heart, Lung and Pancreas during organ transplantation and by some of the leading Cardiac Surgery Centers as a cardioplegic solution in cardiac surgery..

Custodiol® a product approved by the US FDA as a Medical Device and being a Multi-Organ solution is also the solution of choice as an organ preservation solution for Non-Heart Beating Donor Transplantation.

Indications of Custodiol® (HTK solution) include cardioplegia, organ protection and surface cooling of the heart, liver and kidney in situ as well as for transportation of organs from donor to recipient. Custodiol® solution is also used for the protection of the venous transplants (coronary vessel replacement, mainly of the great saphenous vein).
In-situ protection Due to high systemic tolerance all kinds of operation procedures in ischemic organs may be perfomed such as heart surgery, kidney tumor resection and split liver donation.

Transplantation

Multi organ procurement using Custodiol® HTK solution

• Reliable preservation of donor organs
• Easier handling due to simultaneous in-situ perfusion of all organs
• Increased organ availability due to excellent postoperative function, even with kidney of non-heart beating donors

Autologous graft protection with Custodiol® HTK solution

• Excellent preservation of venous and arterial grafts
• Reduced rise in permeability of the endothelial cell layer
• Effective even at room temperature

Custodiol® HTK solution for Cardiac surgery and Transplantation

• High rate of spontaneous return to sinus rhythm
• Minimized cell necrosis
• Less depletion of ATP stores
• Remarkably increased protective potency

Liver Transplantation with Custodiol® HTK solution

• Extended cold preservation time
• Better preservation of micro-circulation
• Low degree of cell edema
• Prevention of leukocyte adhesion
• Reduced biliary tract complications

Kidney Transplantation with Custodiol® HTK solution

• Rapid graft function
• Prolongation of ischemic tolerance
• Lower frequency of post-operative dialysis
• Shortened hospitalization
• Good Structural protection even at 25 °C
• High rate of long time graft survival
  

Heart Transplantation with Custodiol® HTK solution

• High rate of spontaneous return to sinus rhythm
• Minimized cell necrosis
• Less depletion of ATP stores
• Remarkably increased protective potency

Lung Transplantation with Custodiol® HTK solution

• Good pulmonary tissue preservation in conjunction with prostaglandins, excellent postoperative functional result
• Low post-transplant pulmonary edema
• Good preservation of combined heart-lung graft

Pancreas Transplantation with Custodiol® HTK solution

• Good endocrine and exocrine function of pancreatic tissue post-operatively
• Suitable for in-situ flush of human pancreases prior to subsequent islet isolation, culture and transplantation
• Reliable graft function in a porcine model after upto 24 hours cold storage

Properties of Custodiol® HTK solution

• Low potassium concentration to minimize risks
• Low sodium concentration for safe organ inactivation
• Extended buffer capacity only possible with high histidine / histidine-Hcl concentration
• Tryptophane supports membrane integrity
• Alpha- ketoglutarate serves as a substrate for aerobic energy production during the induction of cardioplegia, and when restarting the heart
• HTK is perfused as a cold solution, so that its hypothermic effect contributes to a decreased metabolic rate
• All components of HTK solution are naturally occurring physiological substances except for the inert mannitol, therefore no toxic effects have ever been observed

Advantages of Custodiol® HTK solution

• Use in-situ and during hypothermic storage
• Rapid homogenous cooling due to low viscosity
• Superior recovery of function
• Excellent ischemic tolerance
• High buffering capacity
• Easier surgical handling due to excellent visibility
• Reduced risk of post-aggression syndrome
• Virtual absence of side effects
• Simple perfusion technique (ready-to-use, no additives or preparation) saves cost of filters, additives and staff time
• Shortened postoperative intensive care period

Presentation of Custodiol® HTK solution

• 5 litre bag (cartons of 2 bags)
• 2 litre bag (cartons of 4 bags)
• 1 litre bottle (cartons of 6 bottles)
• 500 ml bottle (cartons of 10 bottles)

The Custodiol® bag, Cryovac M312, is made of a new generation of advanced films for medical solutions. The material is based on exclusive multilayer technology resulting in a film that is exceptionally clear, extremely durable with a wide range of superior physical properties.

Storage
8 - 15 °C

Shelf-Life
1 year

Composition: 1000ml of the solution contains
0.8766g	Sodium Chloride	15.0 mmol
0.6710g	Potassium Chloride	9.0 mmol
0.8132g	Magnesium Chloride
6.000	H2O	4.0 mmol
3.7733g	Histidine Hydrochloride Monohydrate	18.0 mmol
27.9289	Histidine	180.0 mmol
0.4045g	Tryptophan	2.0 mmol
5.4651g	Mannitol	30.0 mmol
0.0022g	Calcium Chloride
2.000	H2O	0.015 mmol
0.1842g	Potassium Hydrogen 2 Ketoglutarate	1.0 mmol

Presentation of CUSTODIOL
BOTTLES OF:	100 ml	500 ml	1000 ml
PLASTIC BAGS OF:	1000 ml	2000 ml	5000 ml