Levy 2011.
| Methods | Single‐centre randomized controlled trial, University hospital; France | |
| Participants | Adult participants with cardiogenic shock. Mean age 65 years, 30% female, SAP II score 51, SOFA score 8.5 acute or chronic heart failure with EF < 30% or CI < 2.2 L/min/m2 and systolic blood pressure: < 90 mm Hg; MAP < 60 mm Hg or drop in MAP > 30 mm Hg despite dobutamine up to 10 µg/kg/min and dopamine up to 20 µg/kg/min (N = 30) |
|
| Interventions | Epinephrine (mean dose 0.15 µg/kg/min at 24 hours for 5 days) vs norepinephrine (mean dose 0.13 µg/kg/min at 24 hours) + dobutamine (8 ± 2 µg/kg/min for 5 days) Target MAP between 65 and 70 mm Hg and stable CI |
|
| Outcomes | Mortality 28 days. Vasopressor titration, haemodynamic, metabolic, splanchnic and renal parameters at baseline, 1, 6, 12 and 24 hours | |
| Notes | Before study: Start with dobutamine up to 10 µg/kg/min, then dopamine up to 2 to 20 µg/kg/min, then start study drug and concomitantly stop dopamine. Dobutamine stopped in the epinephrine group Funding: not reported Conflits of interest: none |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization code |
| Allocation concealment (selection bias) | Unclear risk | Consecutive patients, …according to the randomization code |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Complete follow‐up for study period |
| Explicit in‐/exclusion criteria | Low risk | Described explicitly |
| ITT‐analysis | Low risk | Performed |
| Adequate patient description | Low risk | Adequately described |
| Identical care | Unclear risk | Open‐label intervention, no treatment protocol presented |
| Outcome description | Low risk | Clear |
| Physicians blinded | High risk | Not reported/not performed |
| Outcome assessors blinded? | Unclear risk | Low risk for mortality, unclear risk for other outcomes |