Early Versus Late Renal Replacement Therapy After Cardiac Surgery

October 9, 2013 updated by: Giuseppe Crescenzi M.D., Ospedali Riuniti Ancona

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury after cardiac surgery is strongly associated with in-hospital mortality and morbidity. This is an area where effective treatments are lacking and trial are difficult to perform. To date no randomized controlled trial (RCT) has sufficiently estimated the impact of RRT timing of initiation on patient outcome, and the present prospective, controlled, interventional, single-center trial attempts to compare patient outcome with "early" versus "late" initiation of RRT. Previous studies in cardiac surgery setting have been retrospective ones and have been hampered by lead-time bias, and drop out patients. To overcome these biases all patients who underwent cardiac surgery were prospectively enrolled in the trial and were divided in two treatment groups: the "early" approach was used during the first 10-months, and the "late" approach during the next 10-months. To improve the information gained from this non-classical randomized study and to minimize bias, the investigators enrolled almost all patients with few exclusion criteria during two following short periods, used intention-to-treat analysis and treated all patients according to local protocols and international guidelines, except for RRT initiation strategy.

Outcome parameters were hospital mortality, and ICU and hospital length of stay.

"Early" therapy was started after 6 hours of urine output of less than<0,5ml/Kg/h, whereas in the "late" group RRT therapy was started on the basis of persistent (lasting more than 12 hours) oliguria.

Data obtained from the database were analyzed using "Statistical Package for Social Science" (SPSS Inc, Chicago, IL). Continuous variables are presented as mean±SD, categorical variables were summarized as frequencies and percentages. The Student t test or Pearson X square test were performed to evaluate differences between groups and to analyze subgroups. For statistics, a p<0.05 was considered significant.

Power calculation was based on previous reports13 on cumulative mortality following cardiac surgery. 50% reduction of mortality was hypothesized when the more conservative approach to cardiac surgery-AKI was applied. The suggested number of patients was about 900 patients per group.

The main limitation of the present study include the non-classical randomization, nevertheless we conducted an interventional trial comparing two treatment strategies in two different groups of patients, prospectively followed and suitable for both treatments.

Study Type

Interventional

Enrollment (Actual)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AN
      • Ancona, AN, Italy, 60100
        • Cardiac Surgery department of Ospedali Riuniti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients submitted to cardiac surgery at "Ospedali Riuniti" of Ancona during the study period
  • Planned use of extracorporeal circulation

Exclusion criteria:

  • Preoperative dialysis
  • Planned off-pump cardiac surgery
  • Pts (or proxy) did not sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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: 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
Active Comparator: 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 (<0,5 ml/Kg/h >12h), despite therapy
  • refractory extravascular fluid overload
  • azotemia > 40mmol/L or 240 mg/dL
  • metabolic acidosis (pH<7,2)
  • hyperkaliemia (k+>6 mmol/L)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative mortality
Time Frame: death during the same hospitalization as surgery, or after discharge, but within 30 days of surgery
death during the same hospitalization as surgery, or after discharge, but within 30 days of surgery
death during the same hospitalization as surgery, or after discharge, but within 30 days of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: during the same hospitalization for surgery, but within 30 days from surgery
Hospital length of stay (days): from operative day to discharge or death
during the same hospitalization for surgery, but within 30 days from surgery
ICU length of stay
Time Frame: during the same hospitalization for surgery, but within 30 days from surgery
from entrance to ICU after the end of surgery to discharge to ward facilities
during the same hospitalization for surgery, but within 30 days from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedali Riuniti Ancona

Investigators

  • Principal Investigator: Giuseppe Crescenzi, MD, Ospedali Riuniti di Ancona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 6, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 9, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANCCH01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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