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

Sponsor

European Society of Intensive Care Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02341885

Collaborator

(none)

2,000

Enrollment

Location

Duration (Months)

248.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Replacement Therapy Acute Kidney Injury Chronic End Stage Kidney Disease

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 Design

Study Type:

Observational

Actual Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Prevalence of severe AKI [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.