ARDS (Acute Respiratory Distress Syndrome), ECMO and Acute MI, ECMO Treatment, Respiratory Failure Patients Treated With ECMO, Shock, Cardiogenic
Conditions
Keywords
Ciprofol, ECMO, Oxygenator function, Sedative, Randomized Controlled Trial, Midazolam, Oxygenator thrombosis
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.
Interventions
DRUGCiprofol
Continuous intravenous infusion (0.05-0.3 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).
DRUGMidazolam
Continuous intravenous infusion (0.02-0.1 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).
Sponsors
First Affiliated Hospital of Wannan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Oxygenator Dysfunction | At Day 3 and Day 7 of ECMO support | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-oxygenator Oxygenation Index (PaO₂/FiO₂ Ratio) | Daily from Day 1 to Day 7 | The post-oxygenator PaO₂/FiO₂ ratio will be measured daily to evaluate oxygenator efficiency. A value \<200 mmHg indicates impaired oxygenation capacity. |
| Oxygenator Lifespan | Through ECMO weaning or Day 30, whichever comes first | Definition: Time (hours) from ECMO initiation to oxygenator replacement. Replacement Criteria: Meeting ≥2 composite dysfunction criteria. |
| Lipid Profile Changes | At 24 hours, 72 hours, and Day 7 | Measure: Serum triglycerides (TG) |
| Plasma D-dimer Concentration (μg/mL) | At 24 hours, 72 hours, and Day 7 post-ECMO initiation. | 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). |
| Incidence of delirium | At 24h post-sedation discontinuation | — |
| ECMO Pump Head Malfunction | During ECMO support (up to 30 days) | 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) |
| Oxygenator Transmembrane Pressure (TMP) Gradients | Daily from Day 1 to Day 7 | 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 |
| ECMO Weaning Success | Through study completion (Day 30) | Definition: Successful decannulation without re-initiation of ECMO within 24 hours. |
| 7-day mortality rate | At Day 7 | All-cause death rate at Day 7 post-ECMO initiation. |
| 28-day mortality rate | At Day 28 | All-cause death rate at Day 28 post-ECMO initiation. |
| ICU Length of Stay (LOS) | Through hospital discharge, up to 90 days | Duration from ICU admission to discharge (days). |
| Duration of Mechanical Ventilation | From ECMO initiation to successful extubation (up to 28 days) | Measure: Time (hours) from intubation to sustained extubation (48 hours without reintubation). |
| Thromboembolic Events | From ECMO initiation until 48 hours after decannulation | 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 |
Contacts
Primary ContactQiancheng Xu
Outcome results
None listed