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

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: Recruiting
• Conditions: Fluid Overload
• Intervention / Treatment: Device: Ultrafiltration

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: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neil Cody, MBChB; Phone Number: 00447525261112; Email: neil.cody@nhs.net

Study Locations

• United Kingdom
  • Down
    • Belfast, Down, United Kingdom, BT97AB
      • Recruiting
      • Belfast City Hospital
      • Contact: Jon Silversides, PhD
      • Principal Investigator: Neil Cody, MBChB

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of patients with daily fluid balance within 500 mL of prescribed target	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	Ensuring that the process of haemofiltration does not result in unacceptable levels of thrombotic events	5 days per patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients developing citrate accumulation	Defined as systemic total:ionised calcium ratio greater than 2.5	5 days
Number of patients developing metabolic alkalosis	Defined as new onset Bicarbonate>30 and pH >7.5	5 days
Number of patients developing metabolic acidosis	Defined as new onset Bicarbonate<18 and pH<7.30	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	5 days per patient
Number of patients developing new onset hyponatraemia	Defined as new onset sodium <130mmol/l	5 days per patient
Number of patients developing new onset hypernatraemia	Defined as new onset sodium >150mmol/l	5 days per patient
Number of patients developing new onset hypokalaemia	Defined as new onset potassium < 3mmol/l	5 days per patient

Collaborators and Investigators

• Sponsor: Belfast Health and Social Care Trust
• Investigators: Principal Investigator: Jon Silversides, PhD, BHSCT

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Ultrafiltration; Deresuscitation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID 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