NCT05036616

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

August 26, 2021

Last Update Submit

December 13, 2025

Conditions

AKI

Keywords

CRRTECMOintegrationcircuitcombination

Outcome Measures

Primary Outcomes (1)

  • CRRT Circuit lifespan

    The time until a CVVHDF malfunction was identified

    72 hours, extended maximum to 120 hours

Secondary Outcomes (3)

  • Serious Adverse Events

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

  • 28-day mortality

    28-day after randomization

  • Pressure at various points of CRRT circuit

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

Study Arms (2)

Separation technique

EXPERIMENTAL
Device: Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy

Integration technique

EXPERIMENTAL
Device: Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy

Interventions

Combination of extracorporeal membrane oxygenation and continuous renal replacement therapyDEVICE

Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy

Integration techniqueSeparation technique

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sasipha tachaboon

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (3)

  • Thy M, Augustin P, Tran-Dinh A, Montravers P, de Tymowski C. Renal Replacement Therapy for Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter International Survey. Blood Purif. 2022;51(11):899-906. doi: 10.1159/000522398. Epub 2022 Apr 7.

    PMID: 35390796BACKGROUND

  • de Tymowski C, Desmard M, Lortat-Jacob B, Pellenc Q, Alkhoder S, Alouache A, Fritz B, Montravers P, Augustin P. Impact of connecting continuous renal replacement therapy to the extracorporeal membrane oxygenation circuit. Anaesth Crit Care Pain Med. 2018 Dec;37(6):557-564. doi: 10.1016/j.accpm.2018.02.024. Epub 2018 Mar 20.

    PMID: 29572101BACKGROUND

  • Tangjitaree P, Thanapongsatorn P, Sinjira T, Surinrat E, Suttiruk P, Srisawat N. The comparison of circuit lifespan between integration and separation approach in extracorporeal membrane oxygenation patients requiring continuous renal replacement therapy support: a randomized controlled trial (E-CRRT Trial). Intensive Care Med. 2026 Feb 5. doi: 10.1007/s00134-026-08302-y. Online ahead of print.

    PMID: 41642325DERIVED

MeSH Terms

Interventions

Continuous Renal Replacement Therapy

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Medicine

Study Record Dates

First Submitted

August 26, 2021

First Posted

September 5, 2021

Study Start

April 1, 2021

Primary Completion

March 10, 2025

Study Completion

August 31, 2025

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

TH(1)