Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02341885
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
European Society of Intensive Care Medicine

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
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.

Layout table for study information
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 : March 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Renal outcome [ Time Frame: with a maximum follow up till day 28 following the index study day ]
    Assessment of renal outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intensive Care Unit patients diagnosed with acute kidney injury and chronic end stage kidney disease.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341885


Locations
Layout table for location information
Belgium
All Centres From All Over the World Willing to Contribute Are Welcome
Brussels, Belgium
Sponsors and Collaborators
European Society of Intensive Care Medicine
Investigators
Layout table for investigator information
Principal Investigator: Eric HOSTE, MD University Hospital, Ghent
Publications:
Hoste EAJ, J.A. K, group TAKI-EPIs: The epidemiology of acute kidney injury - Preliminary results of the multicenter international AKI-EPI study. Intensive Care Med 2011, 37: S207

Layout table for additonal information
Responsible Party: European Society of Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT02341885    
Other Study ID Numbers: PEACE
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Keywords provided by European Society of Intensive Care Medicine:
Kidney
Renal replacement
Acute kidney injury
chronic kidney disease
Epidemiology
Prevalence
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency