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OpenTrials
Completed

NCT Number: NCT05036616

Separation Versus Integrated Approach in Combining ECMO With CRRT

This study aimed to compare circuit lifespan of CRRT between Integration and Separation techniques during ECMO support.

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Key information

Conditions

AKI

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sasipha tachaboon

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

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

ECMO patients >18 years old who met the KDIGO criteria for acute kidney injury and required continuous renal replacement therapy (CRRT). Inclusion criteria were as follows:

  • Refractory acidosis, defined as pH < 7.2 or serum bicarbonate (HCO₃-) < 15 mmol/L
  • Refractory volume overload
  • Refractory hyperkalemia, defined as serum potassium (K⁺) > 6.2 mEq/L or presence of electrocardiographic changes
  • Anuria or oliguria, defined as urine output < 0.5 mL/kg/hr for 6-12 hours
  • Elevated BUN >100 mg/dL or presence of uremic symptoms Increased intracranial pressure

Exclusion criteria

  • Pregnancy
  • Heparin contraindication
  • Chronic kidney disease with CRRT
  • AKI with Glomerulonephritis, Interstitial nephritis, Vassculitis or Urinary tract obstruction

Treatment and study plan

Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy

Device

Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy

Primary outcomes

  1. CRRT Circuit lifespan

    Time frame: 72 hours, extended maximum to 120 hours

    The time until a CVVHDF malfunction was identified

Secondary outcomes

  1. Serious Adverse Events

    Time frame: [Time Frame: 72 hours, extended maximum to 120 hours of filter lifespan]

    Bleeding at exit site, systemic bleeding, need for blood transfusion, air embolism, positive-blood culture infection, hemolysis

  2. 28-day mortality

    Time frame: 28-day after randomization

    28-day mortality, status yes or no

  3. Pressure at various points of CRRT circuit

    Time frame: [Time Frame: 72 hours, extended maximum to 120 hours of filter lifespan]

    Pressure point at CRRT circuit; access pressure, return pressure, filter pressure, Pressure drop, and Transmembrane pressure

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Separation Versus Integrated Approach in Combining ECMO With CRRT, a Randomized Controlled Trial

Acronym: E-CRRT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2021
Registry last updated
Dec 19, 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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