The primary objective is to investigate the effect of 6 weeks porcine protein supplementation versus an isocaloric carbohydrate (maltodextrin) on the composite endpoint of physical recovery.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
na IC opname
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A composite endpoint of hand grip strength, Hand-held Dynamometer m. quadriceps
fem, Hand-held Dynamometer m. biceps brachii and 6 Minute walking test at t=2
(hospital discharge), t=3 (day 42 = end of intervention) and t=4 (3 months
follow-up).
Secondary outcome
- Handgrip strength assessed with Jamar dynamometer at T=3.
- Muscle strength leg assessed with HHD m. quadriceps fem. at T=3.
- Muscle strength arm assessed with HHD m. biceps brachii at T=3.
- Exercise capacity assessed with 6 Minute Walking Distance at T=3.
- Lower extremity muscle function assessed with TCST at T=3.
- CPAx at T=2.
- MRCsum at T=2, T=3 and T=4.
- Barthel score at T=3.
- Rockwood Clinical Frailty Scale at T=3.
- Body composition (BIA) at T=2, T=3 and T=4.
- Plasma AA concentrations at T=3.
- ICU readmission after ICU discharge
- Hospital readmission after hospital discharge
- Overall survival status
Background summary
Patients, discharged from the Intensive Care Unit, frequently suffer from
muscle weakness. During ICU stay, people lost their muscle mass, caused by
immobilization and inflammation during critical illness.
The two main factors involved in rehabilitation are exercise and optimal
nutrition intake. Therefore, protein intake is essential for muscle recovery.
Studies showed that protein requirements are often not met. Research has been
done with increased protein intake during ICU stay and in other patient groups
after hospital discharge. These studies showed mixed positive outcomes.
However, a study on protein supplementation during the post-ICU period is
limiting.
Study objective
The primary objective is to investigate the effect of 6 weeks porcine protein
supplementation versus an isocaloric carbohydrate (maltodextrin) on the
composite endpoint of physical recovery.
Study design
A randomiszed controlled double blinded trial.
Intervention
One group receives daily 2 sachets of 22 g porcine protein, so in total 44 g
per day.
The other group receives daily 2 sachets of 21 g maltodextrin, so in total 42 g
per day.
Study burden and risks
In total, 36 mL blood will be collected. For the first sample, blood can be
taken from the arterial line, so patients will hardly notice this. Besides, one
tube of 3 mL will be taken. Later on in the study, blood samples will be taken
from the patients, which can cause little discomfort.
Furthermore, patients will have 4 study days. On 2 days, they are asked to
return to the hospital. On the other 2 days, patients are still in the
hospital. During these appointments, patients have to perform several tests.
They have to perform tests with i.e. the physiotherapist and blood samples will
be collected. The last visit will be planned (if possible) at the same day as
the 3-month follow-up, which is standard of care. In this case, measured will
not be performed twice. And they are asked to fill in the questionnaires. At
T=3 and T=4, patients can fill these in at home. The questionnaires could be
confronting or exhausting.
Patients have to ingest the food supplement twice a day for a period of 6
weeks. And they have to keep a food diary on 8 days during the entire study
period.
Maltodextrin is frequently used in studies, so the risk is very small. The risk
for the protein group is also expected to be very small. High risk groups are
excluded from the study,
Willy Brandtlaan 10
Ede 6716RP
NL
Willy Brandtlaan 10
Ede 6716RP
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18 years
2. Living at home before hospital admission
3. Minimum ICU stay of 72 h
4. Informed consent
Exclusion criteria
1. MRC sum score <= 24 or 48 >= at ICU discharge
2. Barthel Index <14 before ICU admission
3. Allergy/intolerance for study product
4. Serum creatinin > 173 mcmol/l (renal dysfunction)
5. Inclusion in other intervention trial since ICU admission
6. Inflammatory Bowel Disease
7. Zwangerschap
8. Underlying disease in which in the eyes of the attending physician, the
protein or carbohydate supplement could form a risk for the patient
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 | NL79158.091.21 |