Table 2.
Major Differences in Study Design and Methodology between Key Studies of TGC in Critically Ill Adults
| Study (number denotes study reference) | ICU Type, No. of centers, sample size (n) | TGC range vs. control range (mg/dl) | Nutrition support | Primary outcome in TGC vs control range | Hypoglycemia (BG ≤40 mg/dl) in TGC vs control range | Other comments |
|---|---|---|---|---|---|---|
| Van den Berghe17 | Surgical, 1 center, n = 1548 | 80–110 vs. 180–200 | PN » EN, standard protocol, goal calories reached by day 1–2 | ICU all cause mortality: 4.6% vs 8% (p < .04) | 5.1% vs 0.8% | Steroids given as infusions, dedicated study team |
| Van den Berghe18 | Medical, 1 center, n = 1200 | 80–110 vs 180–200 | PN » EN, standard protocol, goal calories reached by day 3–4 | Hospital all cause mortality: 37.3% vs 40% (p = .33) | 18.7% vs 3.1% | Steroids given as boluses, benefit in long stay (> 3 days) patients |
| Brunkhorst19 | Mixed, 18 centers, n = 537 | 80–110 vs 180–200 | PN > EN, standard protocol, goal calories reached by day 5-6 | 28-day all cause mortality: 24.7% vs 26% (p = .74) SOFA score: 7.8 vs 7.7 (p = .88) | 17% vs 4.1% | Stopped early for safety reasons, based on Leuven protocol |
| Preiser20 | Mixed, 21 centers n = 1101 | 80–110 vs 140–180 | EN > PN, no standard protocol, no nutrition support for > 50% of ICU days | ICU all cause mortality: 17.2% vs 15.3% (p = .41) | 8.7% vs 2.7% | Stopped early due to multiple protocol violations |
| NICE-SUGAR21 | Mixed, 42 centers n = 6104 | 81–108 vs 144–180 | EN » PN, no standard protocol, goal calories reached by day 9–10 | 90-day all cause mortality: 27.5% vs 24.9% (p = .02) | 6.8% vs 0.5% | POCT, multiple sites of sampling |
NICE SUGAR, normoglycemia in intensive care evaluation and survival using glucose algorithm regulation; SOFA, sequential organ failure assessment; POCT, point-of-care testing.