Fluid OverloadSCUFFDNCT05431491
Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients
A study testing Ultrafiltration in people with Fluid Overload, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
To determine the feasibility and safety of deresuscitation using slow continuous ultrafiltration with regional citrate anticoagulation and peripheral or standard central venous access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload
- What is being tested?
- Ultrafiltration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2022to 1 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Adults (>18 years)
- Evidence of fluid overload (greater than trace amount of peripheral oedema in >1 site, pulmonary oedema on chest radiograph, or positive fluid balance equivalent to >5% body weight)
- Clinician intention to target a negative fluid balance
- Expected to remain in a critical care setting beyond the next calendar day
Who cannot join
- Anticipated unavailability of suitable vascular access
- Lack of commitment to full support
- Receiving or imminently planned to receive renal replacement therapy
- Hyponatraemia (Sodium <130mmol/L)
- Hypernatraemia (Sodium >150mmol/L)
- Significant metabolic alkalosis (Bicarbonate>30 and pH>7.5)
Show all 13Show fewer
- Significant metabolic acidosis (HCO3- <18 mmol/l and pH < 7.30)
- Uncorrected hypokalaemia (Potassium <3.0mmol/L)
- Liver failure (Child-Pugh Grade B or above)
- Shock (any of: lactate >3mmol/L, extensive skin mottling, central capillary refill time>3 seconds, more than 1 vasoactive agent in use, noradrenaline dose >0.2 mcg/kg/min, use of dobutamine, adrenaline, milrinone, enoximone or levosimendan)
- Receiving any systemic anticoagulation other than for routine venous thromboembolism prophylaxis, or dual antiplatelet therapy
- Prisoner
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Slow Continuous Ultrafiltration With Regional Anticoagulation for Deresuscitation in Critically Ill Patients Though Standard Central or Peripheral Venous Access.
To determine the feasibility and safety of deresuscitation using slow continuous ultrafiltration with regional citrate anticoagulation and peripheral or standard central venous access.
Read the detailed description
Fluid deresuscitation has been shown to have favourable outcomes in the management of the critically ill patient. Whilst diuretic medications have previously been the mainstay of achieving this deresuscitation, the metabolic and biochemical complications associated with their use can limit their application. Mechanical ultrafiltration is another means of achieving fluid deresuscitation and has theoretical benefits over the use of intravenous diuretics. It allows a more titratable process, without the potential metabolic complications. The use of ultrafiltration has been limited by the requirement of wide bore central venous access. The SCUFFD study is a means of assessing whether ultrafiltration with regional anticoagulation can be achieved through standard central or peripheral venous access.
- Conditions
- Fluid Overload
- Being tested
- Ultrafiltration
- Keywords
- Ultrafiltration, Deresuscitation
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrafiltrationDevice
Ultrafiltration through much smaller intravenous cannula than what has previously been used.
| Study group | Role | What they receive |
|---|---|---|
| Ultrafiltration cohort | Experimental | These patients will be recruited into the study to assess the feasibility of slow continuous ultrafiltration through either a standard central venous catheter, or peripheral intravenous cannula. Receives: Device: Ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with daily fluid balance within 500 mL of prescribed target
Assessing the feasibility of managing to achieve the target fluid balance
Measured: 5 days per patient
Number of patients with filter or circuit thrombosis requiring discontinuation of therapy
Ensuring that the process of haemofiltration does not result in unacceptable levels of thrombotic events
Measured: 5 days per patient
Total volume of fluid removed using ultrafiltration
Assessing the feasibility of fluid removal by ultrafiltration
Measured: 5 days per patient
Circuit lifespan
The lifespan of each ultrafiltration circuit, to assess the feasibility of using this method as a therapeutic option
Measured: 5 days per patient
Secondary outcomes (7)
Number of patients developing citrate accumulation
Defined as systemic total:ionised calcium ratio greater than 2.5
Measured: 5 days
Number of patients developing metabolic alkalosis
Defined as new onset Bicarbonate>30 and pH >7.5
Measured: 5 days
Number of patients developing metabolic acidosis
Defined as new onset Bicarbonate<18 and pH<7.30
Measured: 5 days
Number of patients with a significant change in sodium
Defined as new onset change in sodium >8mmol/l in 24 hours or less
Measured: 5 days per patient
Number of patients developing new onset hyponatraemia
Defined as new onset sodium <130mmol/l
Measured: 5 days per patient
Number of patients developing new onset hypernatraemia
Defined as new onset sodium >150mmol/l
Measured: 5 days per patient
Number of patients developing new onset hypokalaemia
Defined as new onset potassium < 3mmol/l
Measured: 5 days per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start12 Aug 2022
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid OverloadStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Silversides, PhD, Principal investigator, BHSCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431491
- Sponsor's protocol ID
- 21021JS-AS
- Acronym
- SCUFFD
- Status last verified
- Sep 2024
- First submitted
- 20 Jun 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personalized IPD will be available to be share with other researchers. Anonymised data will be grouped into a database which may be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Slow Continuous Ultrafiltration With Regional Anticoagulation for Deresuscitation in Critically Ill Patients Though Standard Central or Peripheral Venous Access.
- ClinicalTrials.gov ID
- NCT05431491
- Acronym / sponsor ID
- SCUFFD / 21021JS-AS
- Conditions
- Fluid Overload
- Keywords
- Ultrafiltration, Deresuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 24 Jun 2022 (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.
To determine the feasibility and safety of deresuscitation using slow continuous ultrafiltration with regional citrate anticoagulation and peripheral or standard central venous access.
Detailed description
Fluid deresuscitation has been shown to have favourable outcomes in the management of the critically ill patient. Whilst diuretic medications have previously been the mainstay of achieving this deresuscitation, the metabolic and biochemical complications associated with their use can limit their application. Mechanical ultrafiltration is another means of achieving fluid deresuscitation and has theoretical benefits over the use of intravenous diuretics. It allows a more titratable process, without the potential metabolic complications. The use of ultrafiltration has been limited by the requirement of wide bore central venous access. The SCUFFD study is a means of assessing whether ultrafiltration with regional anticoagulation can be achieved through standard central or peripheral venous access.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrafiltration cohort | Experimental | Device: UltrafiltrationThese patients will be recruited into the study to assess the feasibility of slow continuous ultrafiltration through either a standard central venous catheter, or peripheral intravenous cannula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (>18 years)
- Evidence of fluid overload (greater than trace amount of peripheral oedema in >1 site, pulmonary oedema on chest radiograph, or positive fluid balance equivalent to >5% body weight)
- Clinician intention to target a negative fluid balance
- Expected to remain in a critical care setting beyond the next calendar day
Key exclusion criteria (13 listed)
- Anticipated unavailability of suitable vascular access
- Lack of commitment to full support
- Receiving or imminently planned to receive renal replacement therapy
- Hyponatraemia (Sodium <130mmol/L)
- Hypernatraemia (Sodium >150mmol/L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrafiltrationUltrafiltration through much smaller intravenous cannula than what has previously been used. | Device | Ultrafiltration cohort |
Primary outcome
Number of patients with daily fluid balance within 500 mL of prescribed target
Time frame: 5 days per patient
Assessing the feasibility of managing to achieve the target fluid balance
Number of patients with filter or circuit thrombosis requiring discontinuation of therapy
Time frame: 5 days per patient
Ensuring that the process of haemofiltration does not result in unacceptable levels of thrombotic events
Total volume of fluid removed using ultrafiltration
Time frame: 5 days per patient
Assessing the feasibility of fluid removal by ultrafiltration
Circuit lifespan
Time frame: 5 days per patient
The lifespan of each ultrafiltration circuit, to assess the feasibility of using this method as a therapeutic option
7 secondary outcomes
Number of patients developing citrate accumulation
Time frame: 5 days
Number of patients developing metabolic alkalosis
Time frame: 5 days
Number of patients developing metabolic acidosis
Time frame: 5 days
Number of patients with a significant change in sodium
Time frame: 5 days per patient
Number of patients developing new onset hyponatraemia
Time frame: 5 days per patient
Number of patients developing new onset hypernatraemia
Time frame: 5 days per patient
Number of patients developing new onset hypokalaemia
Time frame: 5 days per patient
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 2 May 2025.
- Individual participant dataSharing planned: No. No personalized IPD will be available to be share with other researchers. Anonymised data will be grouped into a database which may be shared with other researchers.
Related trials for Fluid Overload
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Acute Kidney Injury, Fluid Overload
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
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Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
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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.
Jon Silversides, PhD principal investigator
BHSCT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrafiltration in people with Fluid Overload, run by Belfast Health and Social Care 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 4 inclusion and 13 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 2 May 2025. 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?
Number of patients with daily fluid balance within 500 mL of prescribed target (time frame: 5 days per patient). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2025.