Table 1 Published RCTs and clinical trials on the use of vasopressors in neonates and children sorted by study design (quality of evidence)
Author, year | Study design | Type of shock/indication for AVP/TP administration | Age | Number of subjects by treatment received | Treatment (medication, dose, duration) | Outcomes | Adverse events | Study period | Oxford levels of evidence 2011 |
|---|---|---|---|---|---|---|---|---|---|
Choong et al., 2009 [29] | Randomized controlled double-blind trial (RCT) | Vasodilatory | 1 month to 17 years | 69 children: 35, AVP; 34, placebo | IV AVP continuous infusion: 0.0005–0.002 units/kg/min | Mortality: AVP, 10/33; placebo, 5/32; p = 0.21 MAP: AVP, increase; placebo, increase; p = 0.02 HR: NA UO: AVP, decrease; placebo, decrease; p = 0.65 Catecholamine requirement: AVP, unchanged; placebo, unchanged; p = 0.93 Vasoactive score: AVP,: unchanged; control, unchanged; p = 0.93 | New onset tachycardia: 0 Tissue ischemia/skin lesions: AVP, 2; placebo, 0; p = 0.15 Cardiac arrest: AVP, 1; placebo, 0; p = 0.55 Rhabdomyolysis: 0 Metabolic acidosis: 0 | 4 years | 1b |
Rios and Kaiser, 2015 [27] | Randomized controlled double-blind trial (RCT) | Refractory hypotension | <24 h (mean age: 6.5 h) | 70 ELBW infants: 10, AVP; 10, dopamine; 50, control | IV AVP continuous infusion: 0.0001–0.0006 units/kg/min | Mortality: AVP, 1/10; dopamine, 1/10; control, 0/50; p = 0.261 MAP: AVP, increase (9/10); dopamine, increase (8/10); control, NA; p = 1.0 HR: AVP, unchanged; dopamine, increase; control, NA; p < 0.01 UO: AVP, unchanged; dopamine, unchanged; control, unchanged; p = 0.384 Catecholamine requirement: AVP, unchanged; placebo, unchanged; p = 0.93 Vasoactive score: NA | New onset tachycardia: 0 Tissue ischemia/skin lesions: AVP, 0: dopamine, 1; control, 2; p = 0.15 Cardiac arrest: AVP, 1; placebo, 0; p = 0.801 Rhabdomyolysis: NA Metabolic acidosis: NA | 2 years | 1b |
Yildizdas et al., 2008 [28] | Clinical, non-blind, controlled trial, | Septic | 1 month to 5.5 years | 58 children: 30, TP; 28, control | IV TP bolus: 20 μg/kg every 6 h | Mortality: TP, 20/30; control, 20/28; p = 0.1 MAP: TP, increase; p = 0.001; control, NA HR: TP, decrease, p = 0.001, control, NA UO: TP, unchanged;, control, unchanged; p = 0.2 Catecholamine requirement: NA Vasoactive score: NA | New onset tachycardia: 0 Tissue ischemia/skin lesions: TP, 5; control, 3; p = 0.3 Cardiac arrest: 0 Rhabdomyolysis: 0 Metabolic acidosis: 0 | 6 months | 1b |
Agrawal et al., 2012 [30] | Clinical trial | Vasodilatory (post-cardiac surgery) | 1 month to 8.5 years | 12 children | IV AVP continuous infusion: 0.0005–0.03 units/kg/min | Mortality: 3/12 Morbidity: NA MAP: increase; p < 0.001 HR: unchanged; p = 0.188 UO: NA Catecholamine requirement: decrease; p < 0.001 Vasoactive score: after AVP, decrease; p = 0.001 | New onset tachycardia: 0 Tissue ischemia/skin lesions: 0 Cardiac arrest: 0 Rhabdomyolysis: 0 Metabolic acidosis: 0 | 6 months | 1c |
Rodriguez-Núñez et al., 2010 [31] | Clinical trial | Septic | 24 days to 15 years | 15 children | IV TP loading dose: 20 μg/kg continuous infusion: 4–20 μg/kg/h | Mortality: 7/15 Morbidity: NA MAP: increase; p < 0.05 HR: decrease; p < 0.05 UO: NA Catecholamine requirement: decrease, p < 0.05 | New onset tachycardia: 0 Tissue ischemia/skin lesions: 4 Cardiac arrest: 1 Rhabdomyolysis: 4 Metabolic acidosis: 3 | 32 months | 1c |
Rodriguez-Núñez et al., 2006 [32] | Clinical trial | Septic | 1 month to 13 years | 16 children | IV TP bolus: 0.02 mg/kg every 4 h, for a maximum of 17 h | Mortality: 9/16 Morbidity: NA MAP: increase; p < 0.01 HR: unchanged; p = not significant UO: NA Catecholamine requirement: decrease; p < 0.05 Vasoactive score: after AVP, decrease; p < 0.05 | New onset tachycardia: 0 Tissue ischemia/skin lesions: 5 Cardiac arrest: 0 Rhabdomyolysis: 2 Metabolic acidosis: 0 | 12 months | 1c |
Bidegain et al., 2010 [34] | Observational-retrospective | Refractory hypotension/septic | 1 day to 8 months | 20 children | IV AVP continuous infusion: 0.00017–0.0007 units/kg/min | Mortality: 13/20 Morbidity: NA MAP: increase; p = 0.002 HR: decrease; p = 0.45 UO: decrease; p = 0.36 Catecholamine requirement: decrease; dopamine, p = 0.006; epinephrine, p = 0.04 | New onset tachycardia: 0 Tissue ischemia/skin lesions: 0 Cardiac arrest: 0 Rhabdomyolysis: 0 Metabolic acidosis: 0 | 2.5 years | 1c |
Matok et al., 2005 [33] | Observational-retrospective | Septic | 4 days to 17.7 years | 14 children | IV TP: loading dose: 7 μg/kg/dose, twice daily maintenance: 20 μg/kg every 6 h | Mortality: 8/14 Morbidity: NA MAP: increase; p = 0.001 HR: decrease; p = 0.003 UO: increase, p = 0.011 Catecholamine requirement: decrease, 8/14; p = NA | New onset tachycardia: 0 Tissue ischemia/skin lesions: 0 Cardiac arrest: 0 Rhabdomyolysis: 0 Metabolic acidosis: 0 | 1 year | 1c |