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

NCT06934811 | Not Yet Recruiting Phase 4

• 1 other identifier: 202507
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  At Day 3 and Day 7 of ECMO support

Secondary Outcomes (13)

• Oxygenator Transmembrane Pressure (TMP) Gradients

  Daily from Day 1 to Day 7

• Post-oxygenator Oxygenation Index (PaO₂/FiO₂ Ratio)

  Daily from Day 1 to Day 7

• Oxygenator Lifespan

  Through ECMO weaning or Day 30, whichever comes first

• Lipid Profile Changes

  At 24 hours, 72 hours, and Day 7

• Plasma D-dimer Concentration (μg/mL)

  At 24 hours, 72 hours, and Day 7 post-ECMO initiation.

Study Arms (2)

Ciprofol group

EXPERIMENTAL

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

Midazolam group

ACTIVE COMPARATOR

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

Interventions

Ciprofol DRUG

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

Ciprofol group

Midazolam DRUG

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

Midazolam group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

MeSH Terms

Conditions

Acute Lung Injury; Shock, Cardiogenic

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Midazolam

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Qiancheng Xu

CONTACT

86-18297529106; qianchengxu@wnmc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 18, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share