Clinical trial NCT06934811: Ciprofol's Impact on Oxygenator Function in Extracorporeal Membrane Oxygenation (ECMO) Patients
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: ECMO Treatment
ARDS (Acute Respiratory Distress Syndrome)
ECMO and Acute MI
Respiratory Failure Patients Treated With ECMO
Shock, Cardiogenic
Keywords: Ciprofol
ECMO
Oxygenator function
Sedative
Randomized Controlled Trial
Midazolam
Oxygenator thrombosis
Lead sponsor: First Affiliated Hospital of Wannan Medical College
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 1. Inclusion Criteria:

   * Receiving ECMO therapy with an anticipated duration exceeding 72 hours;
   * Requiring invasive mechanical ventilation;
   * Requiring sedation and analgesia treatment.
2. 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.

Primary outcomes:
measure: Composite Oxygenator Dysfunction
timeFrame: At Day 3 and Day 7 of ECMO support
Secondary outcomes:
measure: Oxygenator Transmembrane Pressure (TMP) Gradients
timeFrame: Daily from Day 1 to Day 7
measure: Post-oxygenator Oxygenation Index (PaO₂/FiO₂ Ratio)
timeFrame: Daily from Day 1 to Day 7
measure: Oxygenator Lifespan
timeFrame: Through ECMO weaning or Day 30, whichever comes first
measure: Lipid Profile Changes
timeFrame: At 24 hours, 72 hours, and Day 7
measure: Plasma D-dimer Concentration (μg/mL)
timeFrame: At 24 hours, 72 hours, and Day 7 post-ECMO initiation.
measure: Incidence of delirium
timeFrame: At 24h post-sedation discontinuation
measure: ECMO Pump Head Malfunction
timeFrame: During ECMO support (up to 30 days)
measure: Thromboembolic Events
timeFrame: From ECMO initiation until 48 hours after decannulation
measure: ECMO Weaning Success
timeFrame: Through study completion (Day 30)
measure: 7-day mortality rate
timeFrame: At Day 7
measure: 28-day mortality rate
timeFrame: At Day 28
measure: ICU Length of Stay (LOS)
timeFrame: Through hospital discharge, up to 90 days
measure: Duration of Mechanical Ventilation
timeFrame: From ECMO initiation to successful extubation (up to 28 days)
Other outcomes:
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