Altintas 2011.
Methods | RCT, single‐centre, 2‐arm, parallel design | |
Participants |
Total number of randomized participants: 71 Inclusion criteria
Exclusion criteria
Primary diagnoses
Baseline characteristics EN group
PN group
Country: Turkey Setting: university hospital, medical ICU |
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Interventions |
EN group n = 30; 0 losses; ITT analysis Details: preference for postpyloric tube placement, otherwise gastric feeding, feeding initiated within 48 hours, at target rate of 25 to 30 kcal/kg/day using ideal bodyweight, formula with proteins, carbohydrates, and lipids. 20 mL/hour of standard solution, increased every 4 to 6 hours by 20 mL/hour if GRV < 150 mL. Continuous infusion of insulin as needed with target level of 100‐140 mg/kL. Caloric intake received, reported as mean (SD) percentage of target calories given: 46.48 (± 19.34) PN group n = 41; 0 losses; deviations from protocol for 3 participants who were changed to EN feeding due to clinical needs; ITT analysis Details: preference for central or venous route, according to participant condition and contraindications to central venous line insertion, otherwise peripheral route. Target rate of delivery and glycaemic management same as EN group. Feeding started at full dose, unless participant at risk of refeeding syndrome, or severely malnourished and already had electrolyte disturbance. Caloric intake received, reported as mean (SD) percentage of target calories given: percentage of target calories given 66.78 (SD ± 18.85) |
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Outcomes |
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Notes |
Funding/declarations of interest: no details Study dates: February 2004 to January 2006 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quasi‐randomized method of sequence generation. Quote: "Patients were randomized to receive either EN or PN according to the last digit of their assigned hospital record number: odd numbers received PN, and even numbers received EN" |
Allocation concealment (selection bias) | Low risk | Adequate concealment despite inadequate sequence generation. Hospital record numbers were assigned by staff independent of the ICU team |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No details and we assumed investigators made no attempts to blind personnel |
Blinding of outcome assessment (detection bias) All outcomes (except mortality) | Unclear risk | No details |
Blinding of outcome assessment (detection bias) Mortality | Low risk | No details. Lack of blinding unlikely to influence assessment of outcomes for mortality |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent losses but deviations from protocol in 3 participants in PN group. ITT analysis used |
Selective reporting (reporting bias) | Unclear risk | Clinical trials registration not reported. Not possible to make assessment of selective outcome reporting bias |
Baseline characteristics | Unclear risk | More sepsis and acute pathology in PN group; not reported as statistically significant. Unclear if these differences could influence outcome data. Also, we noted that number of participants in each group was not equivalent (41 in PN group; 30 in EN group) and this was not explained |
Other bias | Low risk | Glycaemic controls equivalent between groups. Nutritional goals appeared to be equivalent. No other sources of bias identified |