PrEvalence of Acute and Chronic Kidney Disease Treated by Renal Replacement Therapy (PEACE)

January 21, 2016 updated by: European Society of Intensive Care Medicine

PrEvalence of Acute and Chronic Kidney Disease Treated by Renal Replacement Therapy in the ICU Environment

A prospective international, multi-centre, prevalence study on the epidemiology of the use of renal replacement therapy for ICU patients who have acute kidney injury and chronic end stage kidney disease.

Study Overview

Status

Completed

Conditions

Detailed Description

Acute kidney injury (AKI) is a common finding in intensive care unit (ICU) patients. Approximately 30 to 65% of patients experience an episode of AKI, and 5% of ICU patients are treated with renal replacement therapy. AKI is associated withimportant short term and long-term morbidity as well as mortality, and therefore also with costs. Finally, there is a close link between chronic kidney disease (CKD) and AKI. CKD patients are at greater risk for developing AKI, and survivors of AKI treated with renal replacement therapy (AKI-RRT), may develop chronic kidney disease (CKD) and end stage kidney disease (ESKD).

Different aspects of RRT modality may impact on outcomes, and data that have emerged over the last decade have improved evidence and also rejected commonly accepted dogma. Initial data suggested a better outcome when a higher dose of treatment was applied [5,6]. However, one small and two large prospective randomised controlled trials failed to reproduce these earlier findings. Observational data seems to suggest that continuous RRT (CRRT) modalities are associated with better outcomes. However, relative small, randomized studies and meta-analyses do not demonstrate such a benefit. Observational data suggests that CRRT is associated with improved renal recovery, and also examining the data from the 2 large randomized studies on intensity of RRT suggest that CRRT confers a benefit. Also, despite RRT being available for over 50 years there are no clear consensus guidelines for the initiation of RRT. A recent survey found that up to 89 different combinations of indications are used. Recently, the Acute Kidney Injury Network and the Kidney Disease: Improving Global Outcomes (KDIGO) group, formulated recommendations for this. Recent observational studies indicated that commonly accepted cut offs such as serum urea concentration are probably not that important. Furthermore, timing of initiation may have an effect on outcome. Some studies suggest that early initiation is associated with better outcome, on the other hand others could not demonstrate a benefit and have even demonstrated inferior outcomes.

The most recent survey in Europe showed that CRRT is the preferred modality among intensivists, and that despite the recently published evidence treatment doses are similar to those of a decade ago.

Data on the use of renal replacement therapy (RRT) for AKI and for CKD in ICU patients are either on specific patient groups, such as cardiac surgery patients, based on surveys, or dates back for at least a decade. Furthermore, these studies suffered from exclusion bias, as patients who fulfilled criteria for initiation of RTT, but who were denied RRT, were not considered. That this may be an important consideration is illustrated by findings from a recent small single centre study that demonstrated similar mortality rate between RIFLE-F patients who were and who were not treated with RRT. Therefore, the Acute Kidney Injury Network (AKIN) recommended measuring the epidemiology of AKI.

The investigators anticipate that the evidence that has been generated on different topics of RRT for ICU patients may have influenced current practice. Also, the investigators anticipate regional differences in RRT practice.

Study Type

Observational

Enrollment (Actual)

2000

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

  • Belgium
      • Brussels, Belgium
        • All Centres From All Over the World Willing to Contribute Are Welcome

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

Sampling Method

Non-Probability Sample

Study Population

Intensive Care Unit patients diagnosed with acute kidney injury and chronic end stage kidney disease.

Description

Inclusion Criteria:

  • Patients present in the ICU at time of the study data (date starting at 0:00 h, and ending at 23:59 h) (index ICU stay)
  • ≥18 years of age
  • When required by local EC regulations and EC approval, informed consent (written or oral) by the patient or relative.

Exclusion Criteria:

- none

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
One Group
This is an observational study, aimed at collecting an adequate dataset on a large cohort of patients admitted to a large number of ICUs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of severe AKI
Time Frame: with a maximum follow up till day 28 following the index study day
Assessment of the prevalence of severe AKI (defined as KDIGO class 3) and CKD (defined by treatment with renal replacement therapy (RRT)), in ICU patients, present at time of the study inclusion day
with a maximum follow up till day 28 following the index study day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modalities of RRT
Time Frame: with a maximum follow up till day 28 following the index study day
Assessment of modalities of RRT used for treatment of AKI
with a maximum follow up till day 28 following the index study day
Indications for initiation of RRT
Time Frame: with a maximum follow up till day 28 following the index study day
Assessment of indications for initiation of RRT currently described in literature
with a maximum follow up till day 28 following the index study day
Severity of illness
Time Frame: with a maximum follow up till day 28 following the index study day
Assessment of severity of illness at time of data recording
with a maximum follow up till day 28 following the index study day
Renal outcome
Time Frame: with a maximum follow up till day 28 following the index study day
Assessment of renal outcome
with a maximum follow up till day 28 following the index study day

Collaborators and Investigators

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

Sponsor

European Society of Intensive Care Medicine

Investigators

  • Principal Investigator: Eric HOSTE, MD, University Hospital, Ghent

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

March 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEACE

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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