Separation Versus Integrated Approach in Combining ECMO With CRRT
Sponsor
Chulalongkorn University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05036616
Collaborator
(none)
40
1
33
1.2
Study Details
Study Description
Brief Summary
This investigation aims to evaluate the filter life time of CRRT membrane and complication of combining ECMO and CRRT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Separation Versus Integrated Approach in Combining ECMO With CRRT, a Randomized Controlled Trial
Actual Study Start Date
:
Apr 1, 2021
Anticipated Primary Completion Date
:
Dec 31, 2023
Anticipated Study Completion Date
:
Dec 31, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Separation technique
|
Device: Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy
Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy
|
| Integration technique
|
Device: Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy
Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy
|
Outcome Measures
Primary Outcome Measures
- Circuit lifetime [72 hours]
The time until a CVVH malfunction was identified
Secondary Outcome Measures
- Cost-Effectiveness [72 hours]
To evaluate the cost utility of CRRT between 2 groups
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
18 years
-
Refractory acidosis (pH<7.2 or HCO3<15)
-
Refractory volume overload
-
Refractory hyperkalemia (K>6.2mEq/L or EKG change)
-
Anuria or oliguria (urine output <0.5 mL/kg/hr for 6-12hr)
-
High BUN >100 mg/dL or uremic symptom
-
Increase intracranial pressure
Exclusion Criteria:
-
Pregnancy
-
Not use heparin in ECMO
-
Chronic kidney disease with CRRT
-
AKI with Glomerulonephritis, Interstitial nephritis, Vassculitis or Urinary tract obstruction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sasipha tachaboon | Bangkok | Thailand | 10330 |
Sponsors and Collaborators
- Chulalongkorn University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nattachai Srisawat ,M.D.,
Faculty of Medicine,
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT05036616
Other Study ID Numbers:
- IRB.151/64
First Posted:
Sep 5, 2021
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No