Ciprofol's Impact on Oxygenator Function in Extracorporeal Membrane Oxygenation (ECMO) Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ciprofol, Midazolam.
- Who it may be relevant to
- Registry conditions: ECMO Treatment, ARDS (Acute Respiratory Distress Syndrome), ECMO and Acute MI, Respiratory Failure Patients Treated With ECMO. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Impact of Ciprofol on Oxygenator Performance in Patients Undergoing Extracorporeal Membrane Oxygenation: A Single-Center Randomized Controlled Trial (CIP-OXY Study)
Overview
This study evaluates the safety and effectiveness of Ciprofol, a new sedative, in critically ill patients receiving Extracorporeal Membrane Oxygenation (ECMO), a life-support system for heart or lung failure. The investigation aims to: Assess how Ciprofol affects the oxygenator, a critical ECMO component responsible for adding oxygen to blood. Compare the safety of Ciprofol to midazolam, a commonly used sedative. Eligibility Criteria Adults aged 18 years or older. Patients receiving ECMO and mechanical ventilation for over 72 hours. Individuals requiring sedation for medical procedures. Study Protocol Participants will be randomly assigned to one of two groups: Ciprofol Group: Initial sedation dose of 0.1 mg/kg, adjusted as needed. Midazolam Group: Initial sedation dose of 0.05 mg/kg, adjusted as needed. Both groups will receive pain management with remifentanil. Sedation levels will be adjusted daily by the clinical team to ensure patient safety and comfort. Outcome Measures Primary: Oxygenator performance (oxygen and carbon dioxide levels) on Days 3 and 7. Secondary: Changes in blood triglyceride and clotting marker (D-dimer) levels, oxygenator lifespan before replacement, and safety outcomes such as low blood pressure, respiratory issues, or allergic reactions. Significance ECMO patients often require prolonged sedation, but current sedatives like midazolam may contribute to oxygenator damage. Ciprofol's potential for faster recovery and fewer side effects could improve sedation practices and device longevity in this high-risk population.
Interventions
- Drug Ciprofol
Continuous intravenous infusion (0.05-0.3 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0). - Drug Midazolam
Continuous intravenous infusion (0.02-0.1 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).
Primary outcome measures
- Composite Oxygenator Dysfunction [Time frame: At Day 3 and Day 7 of ECMO support]
Secondary outcome measures (12)
- Oxygenator Transmembrane Pressure (TMP) Gradients [Time frame: Daily from Day 1 to Day 7]
- Post-oxygenator Oxygenation Index (PaO₂/FiO₂ Ratio) [Time frame: Daily from Day 1 to Day 7]
- Oxygenator Lifespan [Time frame: Through ECMO weaning or Day 30, whichever comes first]
- Lipid Profile Changes [Time frame: At 24 hours, 72 hours, and Day 7]
- Plasma D-dimer Concentration (μg/mL) [Time frame: At 24 hours, 72 hours, and Day 7 post-ECMO initiation.]
- Incidence of delirium [Time frame: At 24h post-sedation discontinuation]
- ECMO Pump Head Malfunction [Time frame: During ECMO support (up to 30 days)]
- Thromboembolic Events [Time frame: From ECMO initiation until 48 hours after decannulation]
- ECMO Weaning Success [Time frame: Through study completion (Day 30)]
- 7-day mortality rate [Time frame: At Day 7]
- 28-day mortality rate [Time frame: At Day 28]
- ICU Length of Stay (LOS) [Time frame: Through hospital discharge, up to 90 days]
Eligibility criteria
- Inclusion Criteria:
- Receiving ECMO therapy with an anticipated duration exceeding 72 hours;
- Requiring invasive mechanical ventilation;
- Requiring sedation and analgesia treatment.
- Exclusion Criteria:
- BMI >45 kg/m²;
- Age <18 years;
- Severe hepatic (Child-Pugh Class C) or renal failure (eGFR <15 mL/min/1.73m²);
- History of severe psychiatric disorders;
- Pregnancy;
- Refusal to sign informed consent;
- Contraindications to midazolam and propofol use.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06934811 · 202507