Soo 2010.
| Study characteristics | ||
| Methods | Randomised controlled trial. Single centre. Blinded investigators | |
| Participants | 40 adult patients undergoing elective CABG or valvular heart surgery (leukodepletion filter (LD) 20, control filter 20) Baseline characteristics: mean age 62 years, 73% male, 18 CABG, 19 valve, 3 both, EF good/moderate/poor (no definition) Inclusion: not stated Exclusion: active infection, emergency operation, pre‐operative corticosteroid therapy, severe asthma or COPD |
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| Interventions | Similar anaesthetic and monitoring techniques were used in both groups. Median sternotomy, 300 units/kg sodium heparin intravenously prior to CPB using a membrane oxygenator primed with crystalloid solution. Mild hypothermia, 32°C Leukodepletion: Pall LG6 arterial line filter Control: standard arterial line filter (no detail) |
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| Outcomes | Intra‐operative: CPB time, aortic cross‐clamp time Bloods measured pre‐op (within 12 hrs of op), 5 mins after x‐clamp release. Total white blood cell count (WBC) (x109),% neutrophil (x109), neutrophil surface adhesion molecule expression: CD11b, CD62L, PSGL‐1. Time to extubation (hrs), duration of postoperative ventilation (hrs), respiratory index (PaO2/FiO2) before extubation (mmHg), total mediastinal chest drainage (ml) cumulatively after 24 hrs in ICU, cardiac function (CKMB‐fraction (after 24 hrs in ICU), amount and duration of inotropic support (hrs), cumulative adrenaline usage (μg/kg/hr), duration of adrenaline usage (hrs), cumulative noradrenaline usage (μg/kg/hr), duration of noradrenaline usage (hrs), highest lactate level (median), max change in serum creatinine (ratio of max post‐op to pre‐op), ICU stay (hrs) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Low risk | Randomisation was achieved with sealed envelopes given to the perfusion department |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete patient numbers reported for all outcomes indicate no study withdrawal |
| Selective reporting (reporting bias) | Low risk | All collected data reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | A record of the filter used for each patient was kept by the perfusion staff. This record was revealed only during data analysis. All other investigators were blinded to the patient allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |