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Open-label Randomized Controlled Trial of Ultra-Protective vs Protective mechanical ventilation strategy in veno-arterial Extracorporeal membrane oxygenation patients with Refractory cardiogenic shock: study protocol for the UPPER trial

Open-label Randomized Controlled Trial of Ultra-Protective vs Protective mechanical ventilation strategy in veno-arterial Extracorporeal membrane oxygenation patients with Refractory cardiogenic shock: study protocol for the UPPER trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067118
Enrollment
Unknown
Registered
2022-12-27
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory cardiogenic shock

Interventions

intervention group:ultra-protective tidal volume
control group:protective tidal volume

Sponsors

jiangsu province hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria target 18 years and older patients receiving VA-ECMO therapy including extracorporeal cardiopulmonary resuscitation(ECPR). Key inclusion criteria also include: (1)onset of IMV more than 72h; (2)not pregnant; (3)with ECMO duration of more than 72h; (4)RCS or CA with cardiac origin; (5)not enrolled in another clinical trial; (6)signing informed consent form by the guardian; (7)description of CPE on high-resolution chest CT by two radiologists with at least 5-year diagnostic experience who are unaware of the clinical diagnosis.

Exclusion criteria

Exclusion criteria: The exclusion criteria for patient enrollment are as follows: (1)trauma; (2)lack of writtten informed consent by next of kin; (3)existence of contraindications for fiberoptic bronchoscopy examination; (4)blurry lung ultrasound image; (5)pneumothorax and massive pleural effusion; (6)use ECMO as a bridge to heart transplantation; and (7) the patients develop adverse events contributed to difficult weaning from IMV(e.g., intracranial hemorrhage, thromboembolism, severe infection).

Design outcomes

Primary

MeasureTime frame
the number of ventilator-free days(VFD) at day 28 after inclusion;

Secondary

MeasureTime frame
respiratory mechanics;lung ultrasound score;pro-inflammatory mediators; total length in day for ECMO weaning;length of stay(LOS) in intensive care unit;LOS in hospital;in-hospital mortality;

Countries

China

Contacts

Public Contactchen xufeng

jiangsu province hospital

cxfyx@njmu.edu.cn13915906015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026