We want to study the effect of glutamine on duration of mechanical ventilation and lenght of stay in ICU or hospital.With the availability of a Point of Care (POCT) measurement of plasma glutamine level a measurement can be performed short after the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
voeding supplementen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Is there a difference in length of mechanical ventilation, length of stay ICU
or length of stay hospital between patients who received enteral glutamine or
not?
Secondary outcome
What is the amount of enteral glutamine supplementation needed to increase the
plasma glutamine level to a level above 420 µmol/l.Is there a difference
between hospital mortality or 6 month mortality between patients who received
enteral glutamine or not?
Is there a relationship between nutritional status ( measured with
bio-impedance vector analysis) and plasma glutamine level?
Is there a relationship between the amount of supplied nutrition and the course
of plasma glutamine levels?
Is there a difference between patients admitted with sepsis or trauma compared
to other causes of admission?
Background 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 [4]. The ESPEN guidelines recommend 0,2-0,4
g/kg/d intravenous glutamine added to standard parenteral nutrition [9]. Two,
recently published, large randomized controlled studies in critically ill
patients did not show a benefit in survival during supplementation with enteral
and intravenous glutamine [6,7]. The outcome of these trials have led to a
discussion whether it is appropriate to give glutamine supplementation. Several
explanations can be given for these differences in results of the earlier
studies and the two recent trials. It could well be the result of patient
selection; in the Redoxs trial only patients with multiple organ failure were
included whereas these patients were excluded in the earlier trials [7].
Post-hoc analysis of this trial revealed a higher percentage of patients with
acute kidney injury (AKI) who received glutamine supplementation, this could
have influenced outcome as AKI is a strong independent predictor of mortality
during ICU admission [8]. Furthermore, in the Redoxs trial patients received
higher doses of both intravenous and enteral glutamine ( 0,35 g/kg/d i.v. + 30
gram enteral) compared to earlier trials [7]. In the SIGNET trial a total of 20
grams of glutamine was added to parental nutrition; in this trial 47 % of
patients were treated less then 5 days and the amount of parental nutrition is
unclear so the dose of glutamine that patients received was less then 20 grams
per day for most patients [6].
In most clinical trials, glutamine was supplemented without knowledge of the
plasma glutamine levels. It is known that not all patients admitted to the ICU
have a low plasma glutamine level, some patients even show a markedly increased
glutamine level [10]. Previous studies showed a low plasma glutamine level in
31 to 65% of patients at the time of admission on the ICU [2-4].
Study objective
We want to study the effect of glutamine on duration of mechanical ventilation
and lenght of stay in ICU or hospital.
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.
Study design
randomized controlled intervention study
Intervention
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 glutamine ( Glutaperos®, GLNP Life Sciences).
Study burden and risks
no risks
Henri Dunantweg 2
Leeuwarden 8901 BR
NL
Henri Dunantweg 2
Leeuwarden 8901 BR
NL
Listed location countries
Age
Inclusion criteria
All patients admitted to the ICU with an expected stay of 48 hours or longer
Exclusion criteria
age under 18 years, readmission to the ICU, contra-indication for enteral nutrition and the use of Total Parental Nutrition
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL57347.099.16 |