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Early Versus Late Renal Replacement Therapy After Cardiac Surgery

NCT01961999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2013-10-14

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Early RRT

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

PROCEDURE

Late RRT

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)

Sponsors & Collaborators

  • Ospedali Riuniti Ancona

    lead OTHER

Principal Investigators

  • Giuseppe Crescenzi, MD · Ospedali Riuniti di Ancona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961999 on ClinicalTrials.gov