Renal Replacement Anticoagulant Management (RRAM)

November 21, 2019 updated by: Intensive Care National Audit & Research Centre

Observational comparative effectiveness study of individual patient data using interrupted time series analysis techniques of linked data sources to establish clinical and health economic effects of moving from systemic heparin anticoagulation to regional citrate anticoagulation during continuous renal replacement therapy (CRRT) for patients treated on non-specialist Intensive Care Units (ICUs) in England and Wales.

Study Overview

Status

Unknown

Conditions

Critical Illness

Detailed Description

RRAM is an observational comparative effectiveness and cost-effectiveness study of individual patient data using interrupted time series analysis techniques and linked data sources. This study will use existing high quality clinical data collected for the Case Mix programme (CMP) - the national clinical audit for adult critical care - linked with Hospital Episodes Statistics, Office for National Statistics, and UK Renal Registry national data sets to establish the clinical and health economic effects of moving from systemic heparin anticoagulation (SHA) to regional citrate anticoagulation (RCA) during CRRT for patients treated on non-specialist ICUs in England and Wales. This will include data from approximately 85,000 patients treated with CRRT between 1 April 2009 and 31 March 2017 in 184 English non-specialist intensive care units within the ICNARC CMP.

Specific objectives of the RRAM are to:

Investigate the short-term benefits, risks, and costs of citrate anticoagulation.
Provide information on the subsequent development of end-stage renal disease (ESRD).
Trial the efficient research techniques, that if successful could be used to track the effects of any change in critical care practice occurring in ICUs in England and Wales over a reasonably short time scale.

Study Type

Observational

Enrollment (Anticipated)

85000

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

United Kingdom
- - London, United Kingdom, WC1V 6AZ
    - Intensive Care National Audit and Research Centre

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically ill adults who received CRRT on one or more day whilst treated on an ICU

Description

Inclusion Criteria:

Age 16 years or greater
Admitted to an ICU participating in the ICNARC Case Mix Programme (CMP) in England between 1 April 2009 and 31st March 2017

Exclusion Criteria:

Pre-existing end-stage renal disease (ESRD)
Admitted to an ICU after kidney or kidney-pancreas transplantation
Primary admission with acute hepatic failure

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: Case-Control
Time Perspectives: Retrospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Regional citrate anticoagulation (RCA) Those receiving regional citrate anticoagulation for CRRT
Systemic heparin anticoagulation (SHA) Those receiving systemic heparin anticoagulation for CRRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality Time Frame: 90-days	All-cause mortality 90 days after first ICU admission in which CRRT was received	90-days
Incremental net monetary benefit Time Frame: 1-year	Incremental net monetary benefit gained at one year	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality Time Frame: 30-days, and 1-year after ICU admission	All-cause mortality at hospital discharge, 30 days and one year after ICU admission	30-days, and 1-year after ICU admission
Days of renal, cardiovascular, and advanced respiratory support whilst in ICU Time Frame: Up to 5 years	Total number of days receiving renal, cardiovascular, and advanced respiratory support	Up to 5 years
Bleeding and thromboembolic episodes Time Frame: During index admission	Occurrence of bleeding and thromboembolic episodes	During index admission
ICU and hospital length of stay Time Frame: Up to 5 years	Length of stay in hospital and ICU	Up to 5 years
Dialysis-dependent renal disease Time Frame: 1-year	Identification of new dialysis-dependent renal disease at 1-year assessed by data linkage with UK Renal Registry	1-year
Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT Time Frame: at 5 years	Lifetime Incremental net monetary benefit gained	at 5 years

Collaborators and Investigators

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

Sponsor

Intensive Care National Audit & Research Centre

Collaborators

University of Oxford

Guy's and St Thomas' NHS Foundation Trust

University of Bristol

Oxford University Hospitals NHS Trust

Royal Surrey County Hospital NHS Foundation Trust

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 (Actual)

April 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

June 1, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ICNARC/02/08/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

An anonymised study dataset will be availablefrom ICNARC on request to the Chief Investigator, subject to any necessary approvals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.