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

Primary Purpose

Fluid Overload

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrafiltration
Sponsored by
Belfast Health and Social Care Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluid Overload focused on measuring Ultrafiltration, Deresuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Belfast City HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrafiltration cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients with daily fluid balance within 500 mL of prescribed target
Assessing the feasibility of managing to achieve the target fluid balance
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

Secondary Outcome Measures

Number of patients developing citrate accumulation
Defined as systemic total:ionised calcium ratio greater than 2.5
Number of patients developing metabolic alkalosis
Defined as new onset Bicarbonate>30 and pH >7.5
Number of patients developing metabolic acidosis
Defined as new onset Bicarbonate<18 and pH<7.30
Number of patients with a significant change in sodium
Defined as new onset change in sodium >8mmol/l in 24 hours or less
Number of patients developing new onset hyponatraemia
Defined as new onset sodium <130mmol/l
Number of patients developing new onset hypernatraemia
Defined as new onset sodium >150mmol/l
Number of patients developing new onset hypokalaemia
Defined as new onset potassium < 3mmol/l

Full Information

First Posted
June 20, 2022
Last Updated
September 6, 2023
Sponsor
Belfast Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05431491
Brief Title
Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients
Acronym
SCUFFD
Official Title
Feasibility of Slow Continuous Ultrafiltration With Regional Anticoagulation for Deresuscitation in Critically Ill Patients Though Standard Central or Peripheral Venous Access.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belfast Health and Social Care Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Overload
Keywords
Ultrafiltration, Deresuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrafiltration cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrafiltration
Intervention Description
Ultrafiltration through much smaller intravenous cannula than what has previously been used.
Primary Outcome Measure Information:
Title
Number of patients with daily fluid balance within 500 mL of prescribed target
Description
Assessing the feasibility of managing to achieve the target fluid balance
Time Frame
5 days per patient
Title
Number of patients with filter or circuit thrombosis requiring discontinuation of therapy
Description
Ensuring that the process of haemofiltration does not result in unacceptable levels of thrombotic events
Time Frame
5 days per patient
Secondary Outcome Measure Information:
Title
Number of patients developing citrate accumulation
Description
Defined as systemic total:ionised calcium ratio greater than 2.5
Time Frame
5 days
Title
Number of patients developing metabolic alkalosis
Description
Defined as new onset Bicarbonate>30 and pH >7.5
Time Frame
5 days
Title
Number of patients developing metabolic acidosis
Description
Defined as new onset Bicarbonate<18 and pH<7.30
Time Frame
5 days
Title
Number of patients with a significant change in sodium
Description
Defined as new onset change in sodium >8mmol/l in 24 hours or less
Time Frame
5 days per patient
Title
Number of patients developing new onset hyponatraemia
Description
Defined as new onset sodium <130mmol/l
Time Frame
5 days per patient
Title
Number of patients developing new onset hypernatraemia
Description
Defined as new onset sodium >150mmol/l
Time Frame
5 days per patient
Title
Number of patients developing new onset hypokalaemia
Description
Defined as new onset potassium < 3mmol/l
Time Frame
5 days per patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Cody, MBChB
Phone
00447525261112
Email
neil.cody@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Silversides, PhD
Organizational Affiliation
BHSCT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Belfast City Hospital
City
Belfast
State/Province
Down
ZIP/Postal Code
BT97AB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Silversides, PhD
First Name & Middle Initial & Last Name & Degree
Neil Cody, MBChB

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients

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