Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients (SCUFFD)

April 29, 2025 updated by: Belfast Health and Social Care Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Down
      • Belfast, Down, United Kingdom, BT97AB
        • Belfast City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ultrafiltration cohort
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.
Device: Ultrafiltration
Ultrafiltration through much smaller intravenous cannula than what has previously been used.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
5 days per patient
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
5 days per patient
Total volume of fluid removed using ultrafiltration
Time Frame: 5 days per patient
Assessing the feasibility of fluid removal by ultrafiltration
5 days per patient
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
5 days per patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients developing citrate accumulation
Time Frame: 5 days
Defined as systemic total:ionised calcium ratio greater than 2.5
5 days
Number of patients developing metabolic alkalosis
Time Frame: 5 days
Defined as new onset Bicarbonate>30 and pH >7.5
5 days
Number of patients developing metabolic acidosis
Time Frame: 5 days
Defined as new onset Bicarbonate<18 and pH<7.30
5 days
Number of patients with a significant change in sodium
Time Frame: 5 days per patient
Defined as new onset change in sodium >8mmol/l in 24 hours or less
5 days per patient
Number of patients developing new onset hyponatraemia
Time Frame: 5 days per patient
Defined as new onset sodium <130mmol/l
5 days per patient
Number of patients developing new onset hypernatraemia
Time Frame: 5 days per patient
Defined as new onset sodium >150mmol/l
5 days per patient
Number of patients developing new onset hypokalaemia
Time Frame: 5 days per patient
Defined as new onset potassium < 3mmol/l
5 days per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Belfast Health and Social Care Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jon Silversides, PhD, BHSCT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21021JS-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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