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. 2016 Feb 15;2016(2):CD003709. doi: 10.1002/14651858.CD003709.pub4

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)
  • Arrhythmias

  • CV events

  • Limb/skin ischaemia

  • Hepatosplanchnic ischaemia

Notes Both groups received “conventional open label norepinephrine”
Grant of IGA MZ CR NR 9284‐3
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