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Glutamine Supplementation

Glutamine Supplementation Guided by Plasma Glutamine Levels

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02738762
Enrollment
0
Registered
2016-04-14
Start date
2017-11-15
Completion date
2018-12-31
Last updated
2018-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glutamine, Length of Stay, Mechanical Ventilation

Keywords

intensive care, glutamine, length of stay

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

Interventions

glutamine supplementation guided by glutamine levels in plasma

Sponsors

Frisius Medisch Centrum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
amount of enteral glutamine supplementation glutamine level10 daysamount of enteral glutamine supplementation needed to increase the plasma
length of mechanical ventilation10 daysdifference in length of mechanical ventilation between two groups

Secondary

MeasureTime frameDescription
hospital mortality6 monthsdifference in hospital mortality between two groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026