CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,800 enrolled
Drug / intervention
Early RRT +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01961999
NCT01961999N/ACompleted

"Early" and "Late" Timing Indication for Starting Renal Replacement Therapy in Acute Renal Failure After Cardiac Surgery: a Prospective, Controlled, Interventional, Single-center Trial

Ospedali Riuniti Ancona·interventional·Posted Oct 14, 2013·Updated Oct 14, 2013

In Brief

A clinical study evaluating Early RRT and Late RRT for Acute Kidney Injury. Completed, enrolled 1,800 participants across 1 site.

Detailed Summary

The question of timing of initiation of renal replacement therapy (RRT), "early" versus "late", has seldom been the focus of high-quality or rigorous evaluation. As a consequence, initiatives aimed at identifying the "optimal timing of initiation of RRT" in acute kidney injury (AKI) have been given the highest priority for investigation by the Acute Kidney Injury Network (AKIN). Accordingly, the investigators conducted a prospective, controlled, interventional trial, comparing two treatment groups in which the only variable was the RRT initiation strategy, to determine whether "early" versus "late" initiation in patients with AKI after cardiac surgery is associated with a survival benefit or more favorable outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 14, 2013
Enrollment StartJul 1, 2011
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.7 years ago

Interventions

Early RRTprocedure

In the "early" arm renal replacement therapy was started on the basis of refractory oliguria: urine output \<0,5ml/Kg/h for \> 6 hours

Late RRTprocedure

In the "late" arm at least one the following criteria must be fulfilled prior to initiation of renal replacement therapy: persistent and refractory oliguria (\<0,5ml/Kg/h \>12h), despite therapy refractory extravascular fluid overload azotemia \>40mmol/L or 240mg/dL metabolic acidosis (pH\<7,2) hyperkaliemia (k+\>6mmol/L)