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NCT Number: NCT06934811

Ciprofol's Impact on Oxygenator Function in Extracorporeal Membrane Oxygenation (ECMO) Patients

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.

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Key information

Conditions

ECMO Treatment ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Cardiovascular Diseases ECMO and Acute MI Heart Diseases Infarction Ischemia Lung Diseases Lung Injury Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Failure Patients Treated With ECMO Respiratory Tract Diseases Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

ciprofol

Drug

Continuous intravenous infusion (0.05-0.3 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).

midazolam

Drug

Continuous intravenous infusion (0.02-0.1 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).

Primary outcomes

  1. Composite Oxygenator Dysfunction

    Time frame: 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 outcomes

  1. Oxygenator Transmembrane Pressure (TMP) Gradients

    Time frame: 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

  2. Post-oxygenator Oxygenation Index (PaO₂/FiO₂ Ratio)

    Time frame: 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.

  3. Oxygenator Lifespan

    Time frame: 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.

  4. Lipid Profile Changes

    Time frame: At 24 hours, 72 hours, and Day 7

    Measure: Serum triglycerides (TG)

  5. Plasma D-dimer Concentration (μg/mL)

    Time frame: 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).

  6. Incidence of delirium

    Time frame: At 24h post-sedation discontinuation

  7. ECMO Pump Head Malfunction

    Time frame: 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)

  8. Thromboembolic Events

    Time frame: 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

  9. ECMO Weaning Success

    Time frame: Through study completion (Day 30)

    Definition: Successful decannulation without re-initiation of ECMO within 24 hours.

  10. 7-day mortality rate

    Time frame: At Day 7

    All-cause death rate at Day 7 post-ECMO initiation.

  11. 28-day mortality rate

    Time frame: At Day 28

    All-cause death rate at Day 28 post-ECMO initiation.

  12. ICU Length of Stay (LOS)

    Time frame: Through hospital discharge, up to 90 days

    Duration from ICU admission to discharge (days).

  13. Duration of Mechanical Ventilation

    Time frame: From ECMO initiation to successful extubation (up to 28 days)

    Measure: Time (hours) from intubation to sustained extubation (48 hours without reintubation).

Study contacts

Contact information is provided by the study sponsor or research team.

Qiancheng Xu

CONTACT

[email protected]

86-18297529106

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Registry information

Official study title

Evaluating the Impact of Ciprofol on Oxygenator Performance in Patients Undergoing Extracorporeal Membrane Oxygenation: A Single-Center Randomized Controlled Trial (CIP-OXY Study)

Acronym: CIP-OXY

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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