The Effect of Simultaneous Renal Replacement Therapy on Extracorporeal Membrane Oxygenation Support for Cardiogenic Shock Patients

NCT ID: NCT02870946

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-09-30

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.

The primary outcome is all-cause 30-day mortality after ECMO is commenced

Detailed Description

Background:

Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. Patients with fluid overload (FO) and sever metabolic disorder in the early phase of ECMO support exhibit higher hospital mortality. Simultaneous renal replacement therapy (RRT) is routinely used to facilitate more rapid metabolic or uremic control and more effective prevention and management of fluid overload when ECMO is commenced in some ECMO centers registered in the Extracorporeal Life Support Organization (ELSO). However, high-quality evidence to support the strategy of simultaneous RRT during ECMO support is currently lacking. The investigators aim to perform a single center, randomized, controlled trial to evaluate the impact of simultaneous RRT on outcomes during ECMO support for CS patients.

Hypotheses:

The investigators hypothesize that simultaneous RRT with ECMO will improve survival, reduce morbidity, and shorten duration on ECMO support, duration on invasive ventilation, total days of ICU stay and hospitalization, and time to recovery from electrolyte disturbance.

Design:

Prospective, single-center, randomized, open-label trial comparing simultaneous RRT and standard care strategies in terms of overall survival.

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. Simultaneous RRT arm: The continuous renal replacement therapy (CRRT) machine is primed and connected to the patient by a "machine in-line" CRRT access after randomization. The drainage tube of the CRRT machine is connected to the ECMO circuit where is after the membrane lung, and the return tube before the membrane lung. The simultaneous RRT begins after ECMO is commenced and finishes when a patient has been weaned from ECMO. If a patient has AKI (The definition is described in outcomes.) after ECMO weaning and fulfills any of the criteria of the following conventional indications, conventional-indication RRT should be delivered with independent CRRT access with a central venous catheter: (1) Serum potassium≥6.0 mmol/L, (2) Serum bicarbonate≤10 mmol/L, or (3) urine output < 0.5 ml/kg/h for 24 hours after ECMO weaning.

2. Standard care arm: Only when a patient demonstrates AKI and fulfills any one of the criteria of the conventional indication mentioned above during ECMO support or after ECMO weaning, conventional-indication RRT should be delivered. The "machine in-line" CRRT access or independent CRRT access is separately used when RRT is delivered during ECMO support or after ECMO weaning.

Primary outcome:

All-cause 30-day mortality after ECMO is commenced.

Secondary outcomes:

Morbidity (acute kidney injury, infection), duration on ECMO support, duration on invasive ventilation, total days of ICU stay and hospitalization, and time to recovery from electrolyte disturbance.

Number of subjects required:

The baseline hospital mortality (66%) of CS patients with ECMO support was obtained from the investigators' previous study. Based on their literature research, early initiation of RRT could reduce the mortality by 18%. Assuming all-cause 30-day mortalities in the control and intervention groups of 66% and 48%, respectively, with a two-sided significance of 0.05 and a power of 0.8, a total of 262 patients (131 for each arm) will be required, including an estimated dropout rate of 10%.

Conditions

Cardiogenic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simultaneous RRT

The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced.

Group Type: EXPERIMENTAL

Simultaneous RRT

Intervention Type: PROCEDURE

The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced. (see Study Description)

Standard care

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.

Group Type: EXPERIMENTAL

Standard care

Intervention Type: PROCEDURE

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.

Interventions

Simultaneous RRT

The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced. (see Study Description)

Intervention Type: PROCEDURE

Standard care

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 and ≤ 70 years.

2. Admission to ICU.

3. 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.

4. ECMO will supply cardiopulmonary support to the patient.

Exclusion Criteria

1. Refusal of consent.

2. Received or decided to receive RRT before ECMO was commenced.

3. 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.

4. Received ECMO bridging to a long-term ventricle assist device or heart transplantation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaotong Hou

Director of Center for Cardiac Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaotong Hou, PhD., Md.

Role: CONTACT

xt.hou@ccmu.edu.cn

86 18911662932

Facility Contacts

Xiaotong Hou, PhD., MD.

Role: primary

xt.hou@ccmu.edu.cn

86 18911662932

Other Identifiers

Z161100000516017

Identifier Type: -

Identifier Source: org_study_id