Therapy Sustained low efficiency dialysis using a single-pass batch system in acute kidney injury - a randomized interventional trial: the REnal Replacement Therapy Study in Intensive Care Unit PatiEnts
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Summary
Posted By:	Gordon S. Doig
E-Mail:	Gordon.Doig@EvidenceBased.net
Posted Date:	8 Aug 2012
Title:	Sustained low efficiency dialysis using a single-pass batch system in acute kidney injury - a randomized interventional trial: the REnal Replacement Therapy Study in Intensive Care Unit PatiEnts
Authors:	Schwenger et al
Reference:	Critical Care 2012, 16:R140 doi:10.1186/cc11445
Link:	Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract:	INTRODUCTION: Acute kidney injury (AKI) is associated with a high mortality of up to 60%. The mode of renal replacement therapy (intermittent versus continuous) has no impact on patient survival. Sustained low efficiency dialysis using a single-pass batch dialysis system (SLED-BD) has recently been introduced for the treatment of dialysis-dependent AKI. To date, however, only limited evidence is available in the comparison of SLED-BD versus continuous veno-venous hemofiltration (CVVH) in intensive care unit (ICU) patients with AKI. METHODS: Prospective, randomized, interventional, clinical study at a surgical intensive care unit of a university hospital. Between April 1st 2006 and January 31st 2009, 232 AKI patients who underwent renal replacement therapy (RRT) were randomized in the study. Follow-up was assessed until August 30th 2009. Patients were either assigned to 12-h SLED-BD or to 24-h predilutional CVVH. Both therapies were performed at a blood flow of 100-120 ml/min. RESULTS: 115 patients were treated with SLED-BD (total number of treatments n=817) and 117 patients with CVVH (total number of treatments n=877).The primary outcome measure, 90-day mortality, was similar between groups (SLED: 49.6% vs. CVVH: 55.6%, P=0.43). Hemodynamic stability did not differ between SLED-BD and CVVH, whereas patients in the SLED-BD group had significantly fewer days of mechanical ventilation (17.7 +/- 19.4 vs. 20.9 +/- 19.8, P=0.047) and fewer days in the ICU (19.6 +/- 20.1 vs. 23.7 +/- 21.9, P=0.04). Patients treated with SLED needed fewer blood transfusions (1,375 +/- 2,573 ml vs. 1,976 +/- 3,316 ml, P=0.02) and had a substantial reduction in nursing time spent for renal replacement therapy (P<0.001) resulting in lower costs. CONCLUSIONS: SLED-BD was associated with reduced nursing time and lower costs compared to CVVH at similar outcomes. In the light of limited health care resources, SLED-BD offers an attractive alternative for the treatment of AKI in ICU patients. Trial registration: ClinicalTrials.gov NCT00322530.
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? (Was allocation concealment maintained?)
	The authors do not explicitly report how allocation concealment was maintained. Although a computer was used to generate the sequence, we do not know how the sequence was executed (Ex. sealed envelopes etc).
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
	5 patients were lost to follow-up for Day 90 outcomes (2 CVVH and 3 SLED) and were analysed as 'alive. Losses were not extensive.
2b. Were patients analyzed in the groups to which they were randomized?
	Yes, patients were analysed in the groups to which they were allocated.
3. Were patients, health workers, and study personnel blind to treatment?
	No, blinding was not used.
4. Were the groups similar at the start of the trial?
	Yes, baseline balance is appropriate.
5. Aside from the experimental intervention, were the groups treated equally?
	The groups appear to have been treated similarly.
What are the Results?
1. How large was the treatment effect?
	There was no difference in mortality. All analyses for continuous outcomes (MV time, ICU stay etc) was conducted with 1-tailed tests, which is likley inappropriate. To be conservative, we recommend DOUBLING any p-value obtained using a 1-tailed analysis. Therefore, p-values for key secondary outcomes become non-significant (Ex. days of MV p-value 0.047 becomes 0.094, ICU stay p-value 0.04 becomes 0.08 etc).
2. How precise was the estimate of the treatment effect?
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care?
	Yes, some ICUs in Australia do use SLED however due to the inappropriate use of 1-talied p-values, SLED may not be as effective as originally reported in this paper.
2. Were all clinically important outcomes considered?
	Yes.
3. Are the likely treatment benefits worth the potential harms and costs?
	Unclear from this current trial.
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