Critical IllnessRRAMNCT03545750
Renal Replacement Anticoagulant Management
An observational study of Critical Illness, run by Intensive Care National Audit & Research Centre at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 85,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill adults who received CRRT on one or more day whilst treated on an ICU
Who may be able to join
- 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
Who cannot join
- Pre-existing end-stage renal disease (ESRD)
- Admitted to an ICU after kidney or kidney-pancreas transplantation
- Primary admission with acute hepatic failure
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Intensive Care National Audit and Research Centre
London, WC1V 6AZ
About this study
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.
Read the 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.
- Conditions
- Critical Illness
- Keywords
- Acute kidney injury, Continuous renal replacement therapy, Citrate, Heparin
- Medical subject headings
- Critical Illness, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Regional citrate anticoagulation (RCA) | Those receiving regional citrate anticoagulation for CRRT | |
| Systemic heparin anticoagulation (SHA) | Those receiving systemic heparin anticoagulation for CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality 90 days after first ICU admission in which CRRT was received
Measured: 90-days
Incremental net monetary benefit
Incremental net monetary benefit gained at one year
Measured: 1-year
Secondary outcomes (6)
All-cause mortality
All-cause mortality at hospital discharge, 30 days and one year after ICU admission
Measured: 30-days, and 1-year after ICU admission
Days of renal, cardiovascular, and advanced respiratory support whilst in ICU
Total number of days receiving renal, cardiovascular, and advanced respiratory support
Measured: Up to 5 years
Bleeding and thromboembolic episodes
Occurrence of bleeding and thromboembolic episodes
Measured: During index admission
ICU and hospital length of stay
Length of stay in hospital and ICU
Measured: Up to 5 years
Dialysis-dependent renal disease
Identification of new dialysis-dependent renal disease at 1-year assessed by data linkage with UK Renal Registry
Measured: 1-year
Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT
Lifetime Incremental net monetary benefit gained
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 85,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intensive Care National Audit & Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Guy's and St Thomas' NHS Foundation Trust, Oxford University Hospitals NHS Trust, Royal Surrey County Hospital NHS Foundation Trust, University of Bristol
- Responsible party
- Sponsor
- Investigators
- Peter Watkinson, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545750
- Sponsor's protocol ID
- ICNARC/02/08/17
- Acronym
- RRAM
- Status last verified
- Nov 2019
- First submitted
- 4 Apr 2018
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymised study dataset will be availablefrom ICNARC on request to the Chief Investigator, subject to any necessary approvals
Publications
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.
PubMed 36033243Gould 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.
PubMed 35212260
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Replacement Anticoagulant Management
- ClinicalTrials.gov ID
- NCT03545750
- Acronym / sponsor ID
- RRAM / ICNARC/02/08/17
- Conditions
- Critical Illness
- Keywords
- Acute kidney injury, Continuous renal replacement therapy, Citrate, Heparin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85,000 participants (estimated)
- Lead sponsor
- Intensive Care National Audit & Research CentreUniversity, hospital or other
- Collaborators
- University of Oxford, Guy's and St Thomas' NHS Foundation Trust, Oxford University Hospitals NHS Trust, Royal Surrey County Hospital NHS Foundation Trust, University of Bristol
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional citrate anticoagulation (RCA) | – | –Those receiving regional citrate anticoagulation for CRRT |
| Systemic heparin anticoagulation (SHA) | – | –Those receiving systemic heparin anticoagulation for CRRT |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill adults who received CRRT on one or more day whilst treated on an ICU
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Pre-existing end-stage renal disease (ESRD)
- Admitted to an ICU after kidney or kidney-pancreas transplantation
- Primary admission with acute hepatic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 90-days
All-cause mortality 90 days after first ICU admission in which CRRT was received
Incremental net monetary benefit
Time frame: 1-year
Incremental net monetary benefit gained at one year
6 secondary outcomes
All-cause mortality
Time frame: 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
Bleeding and thromboembolic episodes
Time frame: During index admission
ICU and hospital length of stay
Time frame: Up to 5 years
Dialysis-dependent renal disease
Time frame: 1-year
Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT
Time frame: at 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Derived from this study: PubMed 36033243Gould 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.
- Derived from this study: PubMed 35212260Gould 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.
- Individual participant dataSharing planned: Yes. An anonymised study dataset will be availablefrom ICNARC on request to the Chief Investigator, subject to any necessary approvals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Watkinson, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Intensive Care National Audit & Research Centre at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 90-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545750, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.