Svoboda 2012.
| Methods | Single‐centre randomized controlled trial, community hospital; Czech Republic | |
| Participants | Adult patients with late advanced refractory septic shock, with blood pressure < 90 mm Hg systolic or < 70 mm Hg mean, who need norepinephrine > 0,6 µg/kg/min for longer than 24 hours after adequate volume resuscitation unless CVP > 12 mm Hg. Mean age = 73 years, 40% female. SOFA score 18, MODS 14 (N = 30) | |
| Interventions | Terlipressin (4 mg/24 h) vs 'no terlipressin' | |
| Outcomes | Mortality at day 3, day 7, day 14, day 28, day 90; haemodynamic response, norepinephrine requirement, changes in MODS and SOFA score, differences in laboratory variables and safety of treatment (serious adverse events)
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| Notes | Both groups received “conventional open label norepinephrine” Grant of IGA MZ CR NR 9284‐3 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random treatment list |
| Allocation concealment (selection bias) | Low risk | Opaque sealed numbered envelopes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data complete |
| Explicit in‐/exclusion criteria | Low risk | Described explicitly |
| ITT‐analysis | High risk | Excluded from analysis were participants who did not survive 3 hours after start of study drug infusion (also for mortality estimates) |
| Adequate patient description | Low risk | Adequately described |
| Identical care | Unclear risk | Open‐label intervention. Open‐label norepinephrine to maintain goal MAP. Target blood pressure determined by the doctor in charge for each individual participant, usually 70 ± 5 mm Hg |
| Outcome description | Low risk | Described |
| Physicians blinded | High risk | Not blinded |
| Outcome assessors blinded? | Unclear risk | Low risk for mortality, high risk for adverse outcomes |