Yildizdas 2008.
| Methods | Single‐centre randomized controlled trial, University hospital PICU (Paediatric Intensive Care Unit); Turkey | |
| Participants | Paediatric participants with septic shock (Hayden 1994; ACCP/SCCM 1992) and non‐response to fluid resuscitation and high‐dose catecholamines Mean age = 28 months, 47% female PRISM score = 29 (N = 58) |
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| Interventions | Terlipressin bolus 20 mcg/kg every 6 hours up to 96 hours (if MAP < 2 SD for age and at discretion of treating physicians) vs Placebo |
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| Outcomes | ICU mortality, ICU LOS, biochemical markers, mechanical ventilation, haemodynamics, adverse events (digital ischaemias). Urine output narratively described as unchanged within the intervention group, but no numbers or between‐group comparisons presented) For the mortality analysis, we used data on ICU mortality |
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| Notes | Placebo administration not described in sufficient detail Funding: not reported Conflict of interest: not declared |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Open random table |
| Allocation concealment (selection bias) | High risk | Open random table |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Implicitly reported |
| Explicit in‐/exclusion criteria | Low risk | Described explicitly |
| ITT‐analysis | Low risk | Performed |
| Adequate patient description | Low risk | Described |
| Identical care | Unclear risk | Catecholamine therapy not described in sufficient detail |
| Outcome description | Low risk | Clear |
| Physicians blinded | High risk | Not blinded |
| Outcome assessors blinded? | Unclear risk | Not reported |
ACCP/SCCM = American College of Chest Physicians/Society of Critical Care Medicine; APACHE´= Acute Physiology and Chronic Health Evaluation; ARDS = acute respiratory distress syndrome; AVP = arginine‐vasopressin; CBI = blood clearance of indocyanine green; CI = cardiac index; CV = cardiovascular; EF = ejection fraction; h = hour; ICU = intensive care unit; IDO2 = index of oxygen delivery; IVO2 = oxygen consumption, indexed; LOS = length of stay; MAP = mean arterial pressure; MODS = multiple organ dysfunction score; NE = norepinephrine; PCCU = Paediatric Critical Care Unit; PELOD = paediatric logistic organ dysfunction score; PICU = paediatric intensive care unit; PRISM = Paediatric Risk of Mortality score; RCT = randomized controlled trial; SAPS = simplified acute physiology score; SBP = systolic blood pressure; ScvO2 = central venous oxygen saturation; SIRS = systemic Inflammatory response syndrome; SOFA = sequential organ failure assessment; SOAP = sepsis occurrence in acutely ill patients; SVRI = systemic vascular resistance index; TNFa = tumour necrosis factor alpha; U = units; VASST (study) = Vasopressin And Septic Shock Trial; VEGF = vascular endothelial growth factor; 2SD = standard deviation