Clinical trial NCT02738762: Glutamine Supplementation
Official title: Glutamine Supplementation Guided by Plasma Glutamine Levels
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glutamine
Length of Stay
Mechanical Ventilation
Keywords: intensive care
glutamine
length of stay
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Earlier studies showed a benefit in survival when glutamine was given intravenously and these studies lead to recommendations that glutamine should be given to critically ill patients. The ESPEN guidelines recommend 0,2-0,4 g/kg/d intravenous glutamine added to standard parenteral nutrition .

Until recently it was not possible to obtain a plasma glutamine level fast enough to consider the result for clinical decision making. With the availability of a Point of Care (POCT) measurement of plasma glutamine level a measurement can be performed short after the collection of blood. This offers the possibility to identify a patient with a low plasma glutamine level shortly after admission and use repeated measurements for evaluation of the response to supplementation of glutamine.

Detailed description: * At admission (day 0) a plasma glutamine level is measured. The measurement can be performed from blood taken for the first arterial blood gas analysis. Patients are eligible for the study when the plasma glutamine level is lower than 420 µmol/l.
* After informed consent is obtained patients are randomised to receive enteral glutamine or not ( the control group). Enteral glutamine supplementation is started (day 1) at a dose of 3 sachets per day given at 6.00, 14.00 and 22.00 hr. A sachet contains 9 grams of L-glutamine ( Glutaperos®, GLNP Life Sciences).
* Enteral glutamine supplementation will be given for a maximum of 10 days or until the patient is discharged from the ICU.
* Plasma glutamine levels will be measured four times a day, at 06.00, 12.00, 18.00 and 00.00 hours, concurrently with the standard arterial blood gas analyses so no extra blood is taken from the patient.
* On day 3 at 12.00 hours the dose of glutamine will be increased to 3 times 2 sachets if plasma glutamine level is still below 420 µmol/l.
* From day 3 ( 12.00 hrs) until day 10 ( end of study) the dosage of enteral glutamine will be evaluated daily at 12.00 hours. When the plasma glutamine level is higher than 420 µmol/l the dosage of enteral glutamine will be adjusted according to the schedule below.
* In patients who randomized to the control group, the plasma glutamine level will be measured daily at 12.00 hr concurrently with standard arterial blood gas analysis

Eligibility criteria: Inclusion Criteria:

* all patients admitted to the ICU with an expected stay of 48 hours or longer
* glutamine level lower thand 420 mmol/l

Exclusion Criteria:

* age under 18 years
* readmission to the ICU
* contra indication for enteral nutrition
* use of total parental nutrition

Primary outcomes:
measure: amount of enteral glutamine supplementation glutamine level
timeFrame: 10 days
measure: length of mechanical ventilation
timeFrame: 10 days
Secondary outcomes:
measure: hospital mortality
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: MCL
name: Matty Koopmans, MSc
role: PRINCIPAL_INVESTIGATOR
References: