ECMO TreatmentPhase 4CIP-OXYNCT06934811
Ciprofol's Impact on Oxygenator Function in Extracorporeal Membrane Oxygenation (ECMO) Patients
A Phase 4 study testing Ciprofol and Midazolam in people with ECMO Treatment and ARDS (Acute Respiratory Distress Syndrome), run by First Affiliated Hospital of Wannan Medical College.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ECMO Treatment, ARDS (Acute Respiratory Distress Syndrome), ECMO and Acute MI
- What is being tested?
- Ciprofol and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Impact of Ciprofol on Oxygenator Performance in Patients Undergoing Extracorporeal Membrane Oxygenation: A Single-Center Randomized Controlled Trial (CIP-OXY Study)
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.
Read more
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
- Being tested
- Ciprofol, Midazolam
- Keywords
- Ciprofol, ECMO, Oxygenator function, Sedative, Randomized Controlled Trial, Midazolam, Oxygenator thrombosis
- Medical subject headings
- Acute Lung Injury, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
Continuous intravenous infusion (0.05-0.3 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).
MidazolamDrug
Continuous intravenous infusion (0.02-0.1 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Day 3 and Day 7 of ECMO support
Secondary outcomes (13)
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
Measured: 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.
Measured: 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.
Measured: Through ECMO weaning or Day 30, whichever comes first
Lipid Profile Changes
Measure: Serum triglycerides (TG)
Measured: 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).
Measured: At 24 hours, 72 hours, and Day 7 post-ECMO initiation.
Incidence of delirium
Measured: 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)
Measured: 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
Measured: From ECMO initiation until 48 hours after decannulation
ECMO Weaning Success
Definition: Successful decannulation without re-initiation of ECMO within 24 hours.
Measured: Through study completion (Day 30)
7-day mortality rate
All-cause death rate at Day 7 post-ECMO initiation.
Measured: At Day 7
28-day mortality rate
All-cause death rate at Day 28 post-ECMO initiation.
Measured: At Day 28
ICU Length of Stay (LOS)
Duration from ICU admission to discharge (days).
Measured: Through hospital discharge, up to 90 days
Duration of Mechanical Ventilation
Measure: Time (hours) from intubation to sustained extubation (48 hours without reintubation).
Measured: From ECMO initiation to successful extubation (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECMO TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934811
- Sponsor's protocol ID
- 202507
- Acronym
- CIP-OXY
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Ciprofol on Oxygenator Performance in Patients Undergoing Extracorporeal Membrane Oxygenation: A Single-Center Randomized Controlled Trial (CIP-OXY Study)
- ClinicalTrials.gov ID
- NCT06934811
- Acronym / sponsor ID
- CIP-OXY / 202507
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol group | Experimental | Drug: CiprofolPatients 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). |
| Midazolam group | Active comparator | Drug: MidazolamPatients 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofolContinuous intravenous infusion (0.05-0.3 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0). | Drug | Ciprofol group |
| MidazolamContinuous intravenous infusion (0.02-0.1 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0). | Drug | Midazolam group |
Primary outcome
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
13 secondary outcomes
Oxygenator Transmembrane Pressure (TMP) Gradients
Time frame: Daily from Day 1 to Day 7
Post-oxygenator Oxygenation Index (PaO₂/FiO₂ Ratio)
Time frame: Daily from Day 1 to Day 7
Oxygenator Lifespan
Time frame: Through ECMO weaning or Day 30, whichever comes first
Lipid Profile Changes
Time frame: At 24 hours, 72 hours, and Day 7
Plasma D-dimer Concentration (μg/mL)
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
Time frame: During ECMO support (up to 30 days)
Thromboembolic Events
Time frame: From ECMO initiation until 48 hours after decannulation
ECMO Weaning Success
Time frame: Through study completion (Day 30)
7-day mortality rate
Time frame: At Day 7
28-day mortality rate
Time frame: At Day 28
ICU Length of Stay (LOS)
Time frame: Through hospital discharge, up to 90 days
Duration of Mechanical Ventilation
Time frame: From ECMO initiation to successful extubation (up to 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofol and Midazolam in people with ECMO Treatment and ARDS (Acute Respiratory Distress Syndrome), run by First Affiliated Hospital of Wannan Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiancheng Xu (86-18297529106, qianchengxu@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Oxygenator Dysfunction (time frame: At Day 3 and Day 7 of ECMO support). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.