60 consecutive critically ill patients will be recruited with illnesses such as severe infection, trauma and post-surgery.
Conditions
Interventions
Trade Name: Dipeptiven
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: N(2) -L-alanyl-L-glutamine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentrati
Sponsors
Barts and the London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18-80 who are likely to remain on the intensive care unit for at least 72 hours as deemed by the consultant in charge of the intensive care unit at the time of admission of the patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy Portasystemic Encephalopathy Prolonged International Normalised Ration (INR) >1.4 Severe Head or Brain Injury Patients not requiring a nagogastric or orogastric tube as part of routine care on the intensive care unit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Critically ill patients often become septic due to severe infection. The function of liver can become strained in this situation, however it is difficult for clinicians to determine how strained the liver actually is. Methionine is an essential amino acid that humans obtain from beef, fish, beet and dairy products. The methionine is metabolised almost exclusively in the liver. Therefore by attaching a radiolabelled carbon 13 atom to the methionine we can measure how much of the methionine has been metabolised and therefore how well the liver is functioning. The primary objective of this study is to show that in critically ill patients the amount of methionine metabolised by the liver is reduced on day 5 in the intensive care unit compared to admission (day 0).;Secondary Objective: 1)In critically ill patients Glutamine is another amino acid which has been shown to be beneficial in critically ill patients. We would like to show that by administering glutamine (in the form of dipeptiven) we can protect the liver from becoming strained in critical illness. (2) Measure glutamine levels in the 3 groups of patients. (3) Measure glutathione peroxidase in the 3 groups. Glutathione peroxidase is a substance in the body which acts against toxic waste products and converts them into water. Glutamine in the body is converted into glutathione and glutathione is essential for glutathione peroxidase to perform its function. (4) We will also measure the effect of giving glutamine has on reducing infections, nutritional status of the patient, length of hospital stay and quality of life of the patient on discharge.;Primary end point(s): The primary endpoint will be change in breath methionine between baseline and day 5 (or last day on ICU if earlier) by group. 12 patients per group will give 80% power to detect differences in the primary outcome of at least one standard deviation assuming a two sided type 1 error of 5%. However, after adjusting for a drop out rate | — |
Countries
United Kingdom
Outcome results
None listed