A Phase 4 interventional study of Ciprofol and Midazolam in ECMO Treatment, ARDS (Acute Respiratory Distress Syndrome) and ECMO and Acute MI, sponsored by First Affiliated Hospital of Wannan Medical College. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by First Affiliated Hospital of Wannan Medical College · Phase 4, Interventional, and Treatment
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →First Affiliated Hospital of Wannan Medical College is the lead sponsor of 36 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Receiving ECMO therapy with an anticipated duration exceeding 72 hours;
BMI >45 kg/m²;
Patients in this arm will receive Ciprofol, an investigational sedative, administered via continuous intravenous infusion. Dosing Protocol: Initial Dose: 0.1 mg/kg loading dose over 1-2 minutes. Maintenance Dose: 0.05-0.3 mg/kg/h, adjusted hourly based on the Richmond Agitation-Sedation Scale (RASS) score (target range: -3 to 0). Combined Analgesia: All patients will concurrently receive remifentanil (0.05-0.3 μg/kg/min) for pain control. Monitoring \& Adjustments: Sedation depth assessed every 30 minutes using RASS and ( Critical-Care Pain Observation Tool) CPOT scores. Dose adjustments made to avoid hypotension (Mean Arterial Pressure) MAP \< 65 mmHg or oversedation. Triglyceride levels monitored daily to guide lipid emulsion management. Safety Measures: Rescue protocol for hypotension (e.g., vasopressors) or respiratory depression (e.g., temporary ECMO flow adjustment).
Drug: Ciprofol
Patients in this arm will receive midazolam, a benzodiazepine sedative commonly used in ECMO patients, administered via continuous intravenous infusion. Dosing Protocol: Initial Dose: 0.05 mg/kg loading dose over 2-5 minutes. Maintenance Dose: 0.02-0.1 mg/kg/h, adjusted hourly based on the RASS score (target range: -3 to 0). Combined Analgesia: All patients will concurrently receive remifentanil (0.05-0.3 μg/kg/min) for pain control, identical to the Ciprofol group. Monitoring \& Adjustments: Sedation depth assessed every 30 minutes using RASS and CPOT scores, consistent with the experimental group. Dose adjustments made to avoid hypotension (MAP \< 65 mmHg) or oversedation. Daily monitoring of drug accumulation markers (e.g., midazolam plasma levels if available). Safety Measures: Rescue protocol for hypotension (e.g., vasopressors) or respiratory depression (e.g., ventilator support escalation).
Drug: Midazolam
Continuous intravenous infusion (0.05-0.3 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).
Continuous intravenous infusion (0.02-0.1 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).
Composite Oxygenator Dysfunction
Definition: Meeting ≥2 of the following: Post-oxygenator PaO₂/FiO₂ \<200 mmHg ΔTransmembrane pressure (ΔdP) ≥20% from baseline or Transmembrane pressure (TMP)\>50 mmHg from baseline CO₂ clearance \<20% \[(Pre-MLCO₂ - Post-MLCO₂)/Pre-MLCO₂\] at gas flow ≥10 L/min
Time frame: At Day 3 and Day 7 of ECMO support
Oxygenator Transmembrane Pressure (TMP) Gradients
Transmembrane pressure (TMP) will be assessed using continuous inline pressure monitoring via the ECMO circuit's integrated pressure sensors (e.g., pre- and post-oxygenator pressure transducers). TMP is calculated as: TMP (mmHg) = Post-oxygenator Pressure - Pre-oxygenator Pressure
Time frame: Daily from Day 1 to Day 7
Post-oxygenator Oxygenation Index (PaO₂/FiO₂ Ratio)
The post-oxygenator PaO₂/FiO₂ ratio will be measured daily to evaluate oxygenator efficiency. A value \<200 mmHg indicates impaired oxygenation capacity.
Time frame: Daily from Day 1 to Day 7
Oxygenator Lifespan
Definition: Time (hours) from ECMO initiation to oxygenator replacement. Replacement Criteria: Meeting ≥2 composite dysfunction criteria.
Time frame: Through ECMO weaning or Day 30, whichever comes first
Lipid Profile Changes
Measure: Serum triglycerides (TG)
Time frame: At 24 hours, 72 hours, and Day 7
Plasma D-dimer Concentration (μg/mL)
Description: Absolute plasma D-dimer levels measured as a biomarker of hypercoagulability and thromboembolic risk. Threshold: \>5 μg/mL (defined as high thrombotic risk per International Society on Thrombosis and Haemostasis \[ISTH\] guidelines).
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
Definition: Occurrence of any of the following: Pump head rupture (visible crack or leak) Pump head thrombosis (ultrasound-confirmed thrombus within the pump housing) Mechanical failure (unplanned pump stoppage requiring emergency intervention)
Time frame: During ECMO support (up to 30 days)
Thromboembolic Events
Definition: Radiologically confirmed: Arterial embolism: Cerebral or limb artery occlusion (CT angiography/ultrasound) Venous thrombosis: Lower extremity DVT or pulmonary embolism (CT pulmonary angiography/Doppler) Intracardiac thrombus: Echocardiographic or CT evidence Grading: Major: Life-threatening or requiring intervention (e.g., thrombectomy) Minor: Asymptomatic or managed medically
Time frame: From ECMO initiation until 48 hours after decannulation
ECMO Weaning Success
Definition: Successful decannulation without re-initiation of ECMO within 24 hours.
Time frame: Through study completion (Day 30)
7-day mortality rate
All-cause death rate at Day 7 post-ECMO initiation.
Time frame: At Day 7
28-day mortality rate
All-cause death rate at Day 28 post-ECMO initiation.
Time frame: At Day 28
ICU Length of Stay (LOS)
Duration from ICU admission to discharge (days).
Time frame: Through hospital discharge, up to 90 days
Duration of Mechanical Ventilation
Measure: Time (hours) from intubation to sustained extubation (48 hours without reintubation).
Time frame: From ECMO initiation to successful extubation (up to 28 days)
No study locations are listed for this record.
Plan to share: No
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First Affiliated Hospital of Wannan Medical College