Acute Renal FailureClicAKINCT03231748
Clearance of Inflammatory Cytokines During Renal Replacement Therapy Using the EMIC®2 Filter
An observational study of Acute Renal Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will be conducted in patients with sepsis and acute kidney injury needing renal replacement therapy. The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter leads to removal of pro-inflammatory middle molecular weight cytokines from the blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2017to 1 Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with sepsis and acute kidney injury who require renal replacement therapy.
Who may be able to join
- adult patients (≥18 years) in the Critical Care Unit with AKI and sepsis
- clinical decision that citrate based continuous veno-venous haemodialysis (CVVHD) is necessary
Who cannot join
- lack of consent
- pre-existing dialysis dependent renal failure
- life expectancy <24 hours
- patients with haemoglobin <7g/dL (unless transfused for clinical reasons)
- need for extracorporeal membrane oxygenation (ECMO)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clearance of Inflammatory Cytokines in Patients With Septic Acute Kidney Injury During Renal Replacement Therapy Using the EMIC®2 Filter
This study will be conducted in patients with sepsis and acute kidney injury needing renal replacement therapy.
The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.
Read the detailed description
In patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy, the investigators aim to determine whether continuous veno-venous haemodialysis with an EMiC®2 filter leads to clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor.
- Conditions
- Acute Renal Failure
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of inflammatory mediators
Clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor
Measured: 48 hours
Secondary outcomes (1)
Adsorption of inflammatory mediators
Adsorption of IL-1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlies Ostermann, PhD, Study director, Guy's & St Thomas Hospital London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231748
- Sponsor's protocol ID
- IRAS ID: 196972
- Acronym
- ClicAKI
- Status last verified
- Oct 2019
- First submitted
- 10 Jul 2017
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lumlertgul N, Hall A, Camporota L, Crichton S, Ostermann M. Clearance of inflammatory cytokines in patients with septic acute kidney injury during renal replacement therapy using the EMiC2 filter (Clic-AKI study). Crit Care. 2021 Jan 28;25(1):39. doi: 10.1186/s13054-021-03476-x.
PubMed 33509215
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearance of Inflammatory Cytokines in Patients With Septic Acute Kidney Injury During Renal Replacement Therapy Using the EMIC®2 Filter
- ClinicalTrials.gov ID
- NCT03231748
- Acronym / sponsor ID
- ClicAKI / IRAS ID: 196972
- Conditions
- Acute Renal Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 27 Jul 2017 (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.
This study will be conducted in patients with sepsis and acute kidney injury needing renal replacement therapy.
The aim is to investigate whether continuous renal replacement therapy with the EMIC®2 filter leads to removal of pro-inflammatory middle molecular weight cytokines from the blood.
Detailed description
In patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy, the investigators aim to determine whether continuous veno-venous haemodialysis with an EMiC®2 filter leads to clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with sepsis and acute kidney injury who require renal replacement therapy.
Key inclusion criteria (2 listed)
- adult patients (≥18 years) in the Critical Care Unit with AKI and sepsis
- clinical decision that citrate based continuous veno-venous haemodialysis (CVVHD) is necessary
Key exclusion criteria (5 listed)
- lack of consent
- pre-existing dialysis dependent renal failure
- life expectancy <24 hours
- patients with haemoglobin <7g/dL (unless transfused for clinical reasons)
- need for extracorporeal membrane oxygenation (ECMO)
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
Removal of inflammatory mediators
Time frame: 48 hours
Clearance of the following mediators Interleukin (IL) -1 alpha, IL-1 beta, IL-2, IL- 4, IL-6, IL-8, IL-10, Tissue necrosis factor alpha (TNF-α), vascular endothelial growth factor (VEGF), Interferon gamma, Monocyte chemotactic protein-1 and epidermal growth factor
1 secondary outcome
Adsorption of inflammatory mediators
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Derived from this study: PubMed 33509215Lumlertgul N, Hall A, Camporota L, Crichton S, Ostermann M. Clearance of inflammatory cytokines in patients with septic acute kidney injury during renal replacement therapy using the EMiC2 filter (Clic-AKI study). Crit Care. 2021 Jan 28;25(1):39. doi: 10.1186/s13054-021-03476-x.
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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.
Marlies Ostermann, PhD study director
Guy's & St Thomas Hospital London
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 Acute Renal Failure, run by Guy's and St Thomas' NHS Foundation Trust 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 5 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: finished, as of the sponsor's last update on 23 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Removal of inflammatory mediators (time frame: 48 hours). 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 NCT03231748, which also lists 1 linked publication.
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 23 Oct 2019.