Renal Replacement Anticoagulant Management

Critical Illness Clinical Trial

— RRAM  

Official title:

Renal Replacement Anticoagulant Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03545750
• Other study ID #: ICNARC/02/08/17
• Status: Active, not recruiting
• Start date: April 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2019
• Source: Intensive Care National Audit & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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:

1. Investigate the short-term benefits, risks, and costs of citrate anticoagulation.

2. Provide information on the subsequent development of end-stage renal disease (ESRD).

3. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85000
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
United Kingdom	Intensive Care National Audit and Research Centre	London

Sponsors (6)

Lead Sponsor	Collaborator
Intensive Care National Audit & Research Centre	Guy's and St Thomas' NHS Foundation Trust, Oxford University Hospitals NHS Trust, Royal Surrey County Hospital NHS Foundation Trust, University of Bristol, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality 90 days after first ICU admission in which CRRT was received	90-days
Primary	Incremental net monetary benefit	Incremental net monetary benefit gained at one year	1-year
Secondary	All-cause mortality	All-cause mortality at hospital discharge, 30 days and one year after ICU admission	30-days, and 1-year after ICU admission
Secondary	Days of renal, cardiovascular, and advanced respiratory support whilst in ICU	Total number of days receiving renal, cardiovascular, and advanced respiratory support	Up to 5 years
Secondary	Bleeding and thromboembolic episodes	Occurrence of bleeding and thromboembolic episodes	During index admission
Secondary	ICU and hospital length of stay	Length of stay in hospital and ICU	Up to 5 years
Secondary	Dialysis-dependent renal disease	Identification of new dialysis-dependent renal disease at 1-year assessed by data linkage with UK Renal Registry	1-year
Secondary	Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT	Lifetime Incremental net monetary benefit gained	at 5 years