Nataloni et al. (1999)

Italy

RCT

PEDro=4

N=45

Population: Head injury; Mean Age=28 yr; Gender: Male=31, Female=14. Group A (n=15): Mean GCS Score=6. Group B (n=15): Mean GCS Score=6. Group C (n=15): Mean GCS Score=5.

Intervention: Patients were randomly administered one of the following feeding conditions: enteral (Group A), parenteral (Group B), or both enteral and parenteral (Group C). Those who participated were expected to stay in ICU for ≥3 days. Feeding began within 2 days of ICU admission and continued for the length of stay.

Outcome Measures: Serum pre-albumin, Retinol-Binding Protein (RBP), nitrogen balance. Assessments were made at baseline and after (day 3, 7 and 11).

1.       Nitrogen balance, which was negative for all groups, improved over the course of treatment; however, it only significantly improved in Group A by day 11 (p<0.0001).

2.       Pre-albumin and RBP significantly increased in Group A compared to both Group B (p<0.001) and Group C (p<0.01). Significant differences in the level of pre-albumin began at day 3 (p<0.01) while the differences in the level of RBP began at day 7 (p<0.01).

Hausmann et al. (1985)

Germany

RCT

PEDro=4

N=20

Population: ABI; Mean Age=28.65 yr; Gender: Male=20; GCS Range=5-7.

Intervention: Patients were randomly assigned to one of the following feeding regimes: Total Parenteral Nutrition (TPN; n=10) or the Combined enteral-parenteral Nutrition (CN; n=10). All received maximal glucose intake of 500 g/day and sorbitol of 100 g/d. Parenteral nutrition was administered continuously via a central venous line over 24 hr. Enteral feeding was administered through a nasogastric tube at 2 hr intervals. Daily fluid balance was corrected with electrolyte solutions or through the use of diuretics. Patients were assessed up to 8 days post injury.

Outcome Measures: Nitrogen Balance (NB), protein concentration.

1.        In the CN group, 4 (40%) patients died, whereas in the TPN group, 2 (20%) patients died. The difference in mortality was not significant.

2.        Regurgitated gastric fluid was lower in the TPN group compared to the CN group going into day 7 (p<0.05).

3.        Protein concentration of the reflux fluid in the CN group (1.1-4.2 g/dl) was significantly elevated compared to the TPN group (0.53-0.84 g/dl) (p<0.05).

4.        Regardless of the feeding regime, NB could not be reached.

Rapp et al. (1983)

USA

RCT

PEDro=4

N=38

Population: Head injury; Standard Enteral Nutrition (SEN) Group (n=18): Mean Age=34.9 yr; Mean GCS Score=7.2. Total Parenteral Nutrition (TPN) Group (n=20): Mean Age=29.2 yr; Mean GCS Score=7.7.

Intervention: Patients were randomly assigned to either the SEN or TPN group. TPN therapy was initiated within 48 hr of admission. EN was given via nasogastric tubes and initiated when tolerated.

Outcome Measures: Nutritional status (serum albumin, nitrogen balance, and daily calorie and nitrogen intake).

1.        No baseline between-group differences with the exception of mean peak temperature during the first 24 hr of hospitalization; TPN group had a higher mean temperature than SEN group (38.6ºC versus 38.0^oC; p=0.02).

2.        Within the 18-day period, 8 of the 18 patients died in the SEN group compared to 0 deaths in the TPN group (p<0.0001).

3.        The TPN group had a significantly greater mean intake in nitrogen/d then the SEN group (10.2 gm versus 4.0 gm; p=0.002); the overall nitrogen balance was also significantly different between groups (p=0.002).

4.        No significant between group difference was found in serum albumin levels over time.

Fan et al. (2016)

China

PCT

N=40

Population: Mean Age=41.69 yr; Gender: Male=62, Female=58.

Intervention: Patients were assigned to receive nutrition Enterally (EN), Parenterally (PN), or both (EN+PN), supported by nutritional therapies. Measures were taken at day 1 and day 20.

Outcome Measures: Nutritional status, complications, clinical outcomes.

1.        Total serum protein was significantly decreased in the PN group (p<0.01) compared to serum protein on day 1, whereas total serum protein was significantly increased in EN and EN+PN groups (p<0.01).

2.        The EN group had significantly higher rates of diarrhea (p<0.01) compared to the PN and EN+PN group.

3.        Stress ulcers were significantly higher in the PN group (p<0.01) than the other two groups.

4.        The EN group had significantly higher rates of aspirated pneumonia (p<0.01). The EN group had the lowest rates of pyemia (p<0.01).

5.        The EN+PN group had the lowest rates of hypoproteinemia (p<0.01) and intracranial infection (p<0.01).

Krakau et al. (2007)

Sweden

Case Control

N=64

Population: TBI; Mean Age=35 yr; Gender: Male=53, Female=11; GCS Score Range=3-8.

Intervention: Patients received Parenteral Nutrition (PN) and Enteral Nutrition (EN), use of gastrostomy, course of assisted feeding.

Outcome Measure: Malnutrition Universal Screening Tool.

1.        While in intensive care, patients received nutrition PN for mean of 19 days.

2.        Most patients (86%) also received EN which was started on average 4 days after injury.

3.        Patients received EN from 1-178 days post PN.

4.        Of the 55 patients receiving EN, 14 received a gastrostomy approximately 1 mo post injury (4 patients continued to depend on gastrostomy at 6 mo).

5.        By 6 mo post injury, 54 (84%) patients were nutritionally independent.

6.        Of the 56 patients assessed for malnourishment, 38 (68%) met the criteria.