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

NCT ID: NCT06934811

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ciprofol group

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).

Group Type: EXPERIMENTAL

Ciprofol

Intervention Type: DRUG

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

Midazolam group

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).

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

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

Interventions

Ciprofol

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

Intervention Type: DRUG

Midazolam

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wannan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Qiancheng Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qiancheng Xu

Role: CONTACT

qianchengxu@wnmc.edu.cn

86-18297529106

Other Identifiers

202507

Identifier Type: -

Identifier Source: org_study_id