Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-11-15
2018-12-31
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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intervention group
enteral glutamine supplementation guided by glutamine level 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
glutamine supplementation
glutamine supplementation guided by glutamine levels in plasma
control group
patients receive normal treatment, no glutamine supplementation
No interventions assigned to this group
Interventions
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glutamine supplementation
glutamine supplementation guided by glutamine levels in plasma
Eligibility Criteria
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Inclusion Criteria
* glutamine level lower thand 420 mmol/l
Exclusion Criteria
* readmission to the ICU
* contra indication for enteral nutrition
* use of total parental nutrition
18 Years
ALL
No
Sponsors
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Frisius Medisch Centrum
OTHER
Responsible Party
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Matty Koopmans
MSc
Principal Investigators
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Matty Koopmans, MSc
Role: PRINCIPAL_INVESTIGATOR
MCL
Other Identifiers
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RTPO 976
Identifier Type: -
Identifier Source: org_study_id
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