Renal Replacement Anticoagulant Management

NCT03545750 | Unknown

• 1 other identifier: ICNARC/02/08/17
• Study Type: observational
• Target: 85,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness

Keywords

Acute kidney injury; Continuous renal replacement therapy; Citrate; Heparin

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  All-cause mortality 90 days after first ICU admission in which CRRT was received

  90-days

• Incremental net monetary benefit

  Incremental net monetary benefit gained at one year

  1-year

Secondary Outcomes (6)

• All-cause mortality

  30-days, and 1-year after ICU admission

• Days of renal, cardiovascular, and advanced respiratory support whilst in ICU

  Up to 5 years

• Bleeding and thromboembolic episodes

  During index admission

• ICU and hospital length of stay

  Up to 5 years

• Dialysis-dependent renal disease

  1-year

Study Arms (2)

Regional citrate anticoagulation (RCA)

Those receiving regional citrate anticoagulation for CRRT

Systemic heparin anticoagulation (SHA)

Those receiving systemic heparin anticoagulation for CRRT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Intensive Care National Audit & Research Centre: lead
• University of Oxford: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Royal Surrey County Hospital NHS Foundation Trust: collaborator
• University of Bristol: collaborator

Study Sites (1)

Intensive Care National Audit and Research Centre

London, WC1V 6AZ, United Kingdom

Location

Related Publications (2)

• Gould DW, Doidge J, Zia Sadique M, Borthwick M, Caskey FJ, Forni L, Lawrence RF, MacEwen C, Mouncey PR, Ostermann M, Harrison DA, Rowan KM, Duncan Young J, Watkinson PJ. Renal replacement anticoagulant management: Protocol and analysis plan for an observational comparative effectiveness study of linked data sources. J Intensive Care Soc. 2022 Aug;23(3):311-317. doi: 10.1177/1751143720913417. Epub 2020 Apr 2.

  PMID: 36033243 DERIVED

• Gould DW, Doidge J, Sadique MZ, Borthwick M, Hatch R, Caskey FJ, Forni L, Lawrence RF, MacEwen C, Ostermann M, Mouncey PR, Harrison DA, Rowan KM, Young JD, Watkinson PJ. Heparin versus citrate anticoagulation for continuous renal replacement therapy in intensive care: the RRAM observational study. Health Technol Assess. 2022 Feb;26(13):1-58. doi: 10.3310/ZXHI9396.

  PMID: 35212260 DERIVED

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Peter Watkinson, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: June 4, 2018
• Study Start: April 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)