Joannes‐Boyau 2013.
| Methods | Country: France, Belgium and Netherlands Setting: multi‐centre ICUs Time frame: 53 months (October 2005‐March 2010) Parallel RCT Intention‐to‐treat analysis: yes Follow‐up period: 90 days Lost to follow‐up: none |
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| Participants | No. randomized: 140 (3 excluded, 1 by steering committee for eligibility reason, 2 for consent reasons) No. analysed: 137 Treatment intervention N = 66 Mean age: 68 years Male, %: 68 SAPS II: 68 Mean APACHE II score: not described Control intervention N = 71 Mean age: 70 years Male, %: 54 Mean SAPS II score: 64 Mean APACHE II score: not described Inclusion criteria Septic shock and AKI (scoring ‘INJURY’ or greater in RIFLE criteria) Exclusion criteria Age ≥ 80 years Estimated life expectancy ≤ 3 months Metastatic cancer Decompensated cirrhosis Acute necrotizing pancreatitis Prior diagnosis of ESRD Confirmed pregnancy Severe coagulopathy Lack of commitment to full medical support |
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| Interventions |
Treatment intervention HVHF 70 mL/kg/h ultrafiltrate flow for 96 hours Blood flow: average blood flow rates 200‐320 mL/min Bicarbonate replacement fluid: replaced one‐third pre‐filter and two‐thirds post‐filter Filter: 1.9 m2 polyethersulfone Control intervention HVHF 35 mL/kg/h ultrafiltrate flow for 96 hours Blood flow: average blood flow rates 200‐320 mL/min Bicarbonate replacement fluid: replaced one‐third pre‐filter and two‐thirds post‐filter Filter: 1.9 m2 polyethersulfone |
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| Outcomes |
Primary endpoint 28‐Day mortality Secondary endpoint Change in haemodynamic profile Change in SOFA and SAPS II scores Duration of mechanical ventilation Duration of RRT and recovery of renal function Duration of stay in ICU and hospital 60‐Day and 90‐day mortality Adverse events attributable to haemofiltration |
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| Notes | Funding source: French Health Ministry One study author declared an award received from a health research organization |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Adequate: block randomization |
| Allocation concealment (selection bias) | Low risk | Adequate: allocation process centralized and allocation group concealed until implementation |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not possible to blind personnel to allocated treatment, although considered to be at low risk |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Trained personnel using standardized report form |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No incomplete data were reported. |
| Selective reporting (reporting bias) | Low risk | Protocol available and predefined outcomes reported |
| Other bias | Low risk | Appears to be free of other sources of bias |
AKI: acute kidney injury.
AN: acrylonitrile.
APACHE II: Acute Physiology and Chronic Health Evaluation II. ARF: acute renal failure. CKD: chronic kidney disease. CVVH: continuous veno‐venous haemofiltration. ESRD: end‐stage renal disease.
HVHF: high‐volume haemofiltration.
INJURY: part of RIFLE (see below) criteria for assessment of severity of acute kidney injury. ICU: intensive care unit.
MAP: mean arterial pressure.
RCT: randomized controlled trial.
RIFLE: "Risk, Injury, Failure, Loss, End‐stage" criteria for assessment of severity of acute kidney injury. RRT: renal replacement therapy. SAPS: Simplified Acute Physiology Score. SOFA: Sequential Organ Failure Assessment score.