Pölönen 2000.
Methods | RCT Single centre |
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Participants | 393 patients 2 groups Elective surgery Cardiac surgery |
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Interventions | Postoperative Fluids and Inotropes Pulmonary artery catheter Goals = SVO2, lactate |
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Outcomes | 28 day, 6 month and 12 month mortality HLOS ICULOS Organ dysfunctions: central nervous system (haemiplegia, stroke, Glasgow coma scale (GCS <10), circulatory (vasoactive medication or intraaortic counterpulsation to treat hypotension or low cardiac output), respiratory (need for mechanical or assisted ventilation), renal (low urine output or increased creatinine), hepatic (increased liver enzymes or bilirubin), gastrointestinal (macroscopic bleeding or paralytic ileus), haematological (low white cell or platelet count) ICU readmission |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomized the day before surgery by sealed envelope technique" |
Allocation concealment (selection bias) | Low risk | See quote above |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Although study was randomized, it was not blinded and the data of the oxygen transport measurements of both groups were open to those taking care of patients during the study period" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | See quote above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Low risk | Published report included all expected outcomes |
Other bias | Unclear risk | 10 patients were excluded after allocation may have induced selection bias |