The Effect of Simultaneous Renal Replacement Therapy on Extracorporeal Membrane Oxygenation Support for Cardiogenic Shock Patients
1 other identifier
interventional
262
1 country
1
Brief Summary
Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. During ECMO support, renal replacement therapy (RRT) facilitate more rapid metabolic or uremic control and more effective prevention and management of fluid overload which happened in critical state. CS patients who are likely to receive ECMO support will be enrolled and randomized with a 1:1 allocation to a simultaneous RRT arm vs. standard care arm.
- 1.The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced.
- 2.The patients in the standard care arm will not receive RRT when ECMO is commenced. Only when a patient demonstrates AKI and fulfills any one of the criteria of the conventional RRT indication during ECMO support or after ECMO weaning, conventional-indication RRT would be delivered.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 8, 2016
CompletedFirst Posted
Study publicly available on registry
August 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJanuary 23, 2019
January 1, 2019
3.1 years
August 8, 2016
January 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality
30 days
Secondary Outcomes (8)
Rate of acute kidney injury
30 days
Rate of infection
30 days
Duration on ECMO support
60 days
Rate of successful weaning from ECMO
30 days
Duration on invasive ventilation
60 days
- +3 more secondary outcomes
Study Arms (2)
Simultaneous RRT
EXPERIMENTALThe patients in the simultaneous RRT arm will receive RRT when ECMO is commenced.
Standard care
EXPERIMENTALThe patients in the standard care arm will not receive RRT when ECMO is commenced. Only when a patient demonstrates AKI and fulfills any one of the criteria of the conventional RRT indication, RRT would be delivered.
Interventions
The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced. (see Study Description)
The patients in the standard care arm will not receive RRT when ECMO is commenced. Only when a patient demonstrates AKI and fulfills any one of the criteria of the conventional RRT indication, RRT would be delivered.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 and ≤ 70 years.
- Admission to ICU.
- Criteria for the diagnosis of CS as follows: (1) systolic blood pressure less than 90 mmHg for 30 min, a mean arterial pressure less than 65 mmHg for 30 min, or vasopressors required to achieve a blood pressure ≥ 90 mmHg; (2) pulmonary congestion or elevated left-ventricular filling pressures; and (3) signs of impaired organ perfusion with at least one of the following criteria: (a) altered mental status; (b) cold, clammy skin; (c) oliguria; and (d) increased serum lactate.
- ECMO will supply cardiopulmonary support to the patient.
You may not qualify if:
- Refusal of consent.
- Received or decided to receive RRT before ECMO was commenced.
- Fulfilled the criteria for Chronic Kidney Disease (either of the following present for \>3 months): (1) Albuminuria (albumin excretion rate \> 30 mg/24 hours; albumin-to-creatinine ratio \> 30 mg/g); (2) urine sediment abnormalities; (3) electrolyte and other abnormalities due to tubular disorders; (4) abnormalities detected by histology; (5) structural abnormalities detected by imaging; and (6) history of kidney transplantation.
- Received ECMO bridging to a long-term ventricle assist device or heart transplantation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Center for Cardiac Intensive Care
Study Record Dates
First Submitted
August 8, 2016
First Posted
August 17, 2016
Study Start
August 1, 2016
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
January 23, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share