it has been found that a particularly suitable composition for the total parenteral nutrition in accordance with the present invention comprises : ______________________________________soybean oil 50 - 200 g / lglycerine 22 - 26 g / legg yolk phospholipids ( ovolecithin ) 10 . 5 - 12 . 5 g / lcarnitine or pharmaceuticallyacceptable salt thereof 5 - 25 g / lsodium hydroxide sufficient to adjust the ph of the composition to 5 . 5 - 9 . 0distilled water balance to 1 liter . ______________________________________ the composition thus obtained is an isotonic intravenous emulsion having an osmolarity of from about 250 to 330 milliosmoles / kg of distilled water . the desired daily dosage will be determined in accordance with standard usage , a daily dosage of 500 ml being generally sufficient . a suitable mode of treating patients in need of total parenteral nutrition is to administer first the above specified emulsion and to continue carnitine administration for a total of 12 to 24 hours . this will ensure that sufficient carnitine is present to maintain high serum levels to increase triglyceride utilization and counterbalance any adverse metabolic effects of the triglycerides . carnitine administration may be , therefore , started by intravenous perfusion and then continue by the oral or parenteral route . as known , carnitine contains an asimmetric atom and consequently exists in two stereoisomers . either the racemate or the isolated isomers can be conveniently used in the method of the present invention , although it appears that the l - isomer is more active , while the d - isomer is slightly more toxic . thus , the ld 50 in rats and mice assessed for various routes of administration according to the litchfield and wilcoxon method is as shown in the following table a . ( litchfield , j . t ., and wilcoxon , f ., j . pharm . exptl . therap . 96 , 99 . 1949 ). table a______________________________________product animal route ld . sub . 50 ( mg / kg ) ______________________________________d , l - carnitine rat i . v . 995d - carnitine &# 34 ; sc 10 , 000d , l - carnitine mouse i . v . 610d , l - carnitine &# 34 ; sc 6 , 000d - carnitine &# 34 ; sc 5 , 400l - carnitine &# 34 ; sc 7 , 000______________________________________ the dose of carnitine which is administered will be determined by the attending physician having regard to the age , weight and condition of the patient , using sound professional judgement . although effective utilization of exogenous glycerides can be noticed at doses as low as from 30 to 50 mg / kg of body weight daily , a dose of from about 150 to about 200 mg / kg of body weight daily is preferred . should it be deemed necessary , larger doses can be safely administered , because of the extremely low toxicity of carnitine . a 63 year old female , patient was hospitalized with duodenocutanous and colocutaneous fistulas ; the fistulas had appeared 20 days earlier , after cholecystectomy and plastic repair of papilla ( through duodenotomy ) which had been complicated by post - surgical occlusion , which had required resection of the small bowel and right colon ( with jejuno - colonic anastomosis ). physical examination showed that general conditions were quite satisfactory ; the patient had no fever ; the entercutaneous fistulas on the abdominal wall were surrounded by areas of mild dermatitis . total output from the fistulas was about 600 ml per day . nothing was allowed via the oral route ; parenteral nutrition started according to the following schedule : 3000 ml daily of solutions containing amino acids , glucose and electrolyte , whose nitrogen / calories intake ratio was 1 : 140 ; 500 ml of 10 % lipid solution with 1 . 4 % carnitine was administered on alternate days . forty - five days later , while main haematological and biochemical parameters were still quite normal , the abdominal wall fistulas had closed spontaneously . the patient was discharged a few days later : oral feedings had been successfully reinstituted and nutritional function was regulard . a 55 year old male patient , was hospitalized because of symptoms of acute pancreatitis which appeared two days previously . upon physical examination , there was slight fever ( 37 . 8 c .°), epigastric tenderness and abdominal distention ; slight muscular resistance was appreciable over the upper abdomen . the patient appeared to be mildly dehydratated ; blood glucose was 208 mg % ml bun 50 mg % ml , serum creatinine 7 . 7 mg % ml , serum diastasis activity 530 u / ml ( normal range : 0 to 80 ). a naso - gastric tube was inserted , and a catheter was placed in right atrium , to monitor central venous pressure . parenteral nutrition was started via the peripheral route , according to the &# 34 ; protein sparing &# 34 ; schedule : 100 g of amino acids , elecrolytes , and a total amount of 5000 ml of daily fluids . a few days later , serum diastasis decreased to normal values , serum glucose was 90 to 130 mg % ml , bun 15 to 35 gm % ml , creatinnine 0 . 7 to 1 . 2 mg % ml , triglycerides 80 to 120 mg % ml , and ketone bodies were found in the urine ; nitrogen balance is quite near to 0 (- 6 , - 4 ). he had lost 10 kg during 15 days . parenteral treatment was now changed by adding a 20 % lipid solution with 2 . 1 % carnitine ( 500 ml on alternate days , by the peripheral route , for 15 days ). this treatment was continued until the patient had almost regained the body weight he had upon admission . during the second part of treatment , we observed a positive nitrogen balance and increasing values of serum triglycerides ; no other significant change was found in the main haematological and biochemical parameters . the patient recovered completly from pancreatitis and underwent cholecystectomy due to cholelithiasis . a 44 year old female patient , was hospitalized in a severe state of sepsis caused by suppuration of pancreatic pseudocyst , which had already been treated by surgical drainage ; 30 days before , in the immediate post partum period , the patient had had a sever episode of pancreatitis . upon phisical examination , patient was in a febrile state : shivering and daily elevations of temperature ( 40 ° c .) were observed . a radiographic study was performed , injecting contrast material using the drainage tube : a little abscess cavity was evident , with several minor irregular branches which stretch towards the upper left quadrant of the abdomen . another surgical operation was required , in order to obtain satisfactory drainage of the cavity . antibiotic therapy was started . the patient began total parenteral nutrition according to the following schedule : 40 % glucose solution , 5 % amino acid solution , electrolytes , 20 % lipid solution with 2 . 5 % carnitine . lipids were administered by the peripheral route , 500 ml on alternate days . the patient was digitalized , and cardiac output rose from 3 . 2 1 / min / mq to 3 . 8 1 / min / mq ; oxygen consumption was 150 - 170 ml / min / mq . on the following days , several episodes of haemodynamic failure were observed , and polyuria appeared ; episodes of shivering and fever were treated by antibiotic therapy . parenteral nutrition was adjusted so that nitrogen / caloric intake ration did not exceed 1 / 120 . fourteen days later , general conditions had improved , fever disappeared , and oral feeding was reinstituted , ( elementary diet ).
a composition for total or supplemental parenteral nutrition of patients in need thereof for the treatment of shock and trauma , is disclosed . the composition comprises a therapeutically effective amount of triglycerides and an amount of carnitine or a pharmaceutically acceptable salt thereof sufficient to increase free fatty acid oxidation .