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Completed

NCT Number: NCT05431491

Feasibility of Slow Continuous UltraFiltration For Deresuscitation in Critically Ill Patients

To determine the feasibility and safety of deresuscitation using slow continuous ultrafiltration with regional citrate anticoagulation and peripheral or standard central venous access.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belfast City Hospital

Belfast, Down, BT97AB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrafiltration

Device

Ultrafiltration through much smaller intravenous cannula than what has previously been used.

Primary outcomes

  1. 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

  2. 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

  3. Total volume of fluid removed using ultrafiltration

    Time frame: 5 days per patient

    Assessing the feasibility of fluid removal by ultrafiltration

  4. 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

Secondary outcomes

  1. Number of patients developing citrate accumulation

    Time frame: 5 days

    Defined as systemic total:ionised calcium ratio greater than 2.5

  2. Number of patients developing metabolic alkalosis

    Time frame: 5 days

    Defined as new onset Bicarbonate>30 and pH >7.5

  3. Number of patients developing metabolic acidosis

    Time frame: 5 days

    Defined as new onset Bicarbonate<18 and pH<7.30

  4. 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. Number of patients developing new onset hyponatraemia

    Time frame: 5 days per patient

    Defined as new onset sodium <130mmol/l

  6. Number of patients developing new onset hypernatraemia

    Time frame: 5 days per patient

    Defined as new onset sodium >150mmol/l

  7. Number of patients developing new onset hypokalaemia

    Time frame: 5 days per patient

    Defined as new onset potassium < 3mmol/l

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Registry information

Official study title

Feasibility of Slow Continuous Ultrafiltration With Regional Anticoagulation for Deresuscitation in Critically Ill Patients Though Standard Central or Peripheral Venous Access.

Acronym: SCUFFD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2022
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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