Separation Versus Integrated Approach in Combining ECMO With CRRT (E-CRRT)

December 13, 2025 updated by: Nattachai Srisawat ,M.D., Chulalongkorn University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • 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 Locations

  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10330
        • Sasipha tachaboon

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

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Patients have to be admitted to the ICU

Description

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:

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

Exclusion Criteria:

  1. Pregnancy
  2. Heparin contraindication
  3. Chronic kidney disease with CRRT
  4. AKI with Glomerulonephritis, Interstitial nephritis, Vassculitis or Urinary tract obstruction

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Separation technique
Device: Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy
Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy
Experimental: Integration technique
Device: Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy
Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRRT Circuit lifespan
Time Frame: 72 hours, extended maximum to 120 hours
The time until a CVVHDF malfunction was identified
72 hours, extended maximum to 120 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
[Time Frame: 72 hours, extended maximum to 120 hours of filter lifespan]
28-day mortality
Time Frame: 28-day after randomization
28-day mortality, status yes or no
28-day after randomization
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
[Time Frame: 72 hours, extended maximum to 120 hours of filter lifespan]

Collaborators and Investigators

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

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2021

Primary Completion (Actual)

March 10, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB.151/64

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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