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Effect of remifentanil versus fentanyl on Lactate Clearance and outcome in mechanically ventilated patients with cardiogenic shock: a randomized controlled trial

Effect of remifentanil versus fentanyl on Lactate Clearance and outcome in mechanically ventilated patients with cardiogenic shock: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117902
Enrollment
Unknown
Registered
2026-01-29
Start date
2026-01-30
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiogenic shock

Interventions

treatment group:The patient was administered remifentanil (4 units of 50 ml, with a concentration of 0.08 mg/ml). The initial bolus injection was 1 ug/kg, with a injection speed of more than 1 minute.
control group:The fentanyl group received a loading dose of 0.35 µg/kg (lasting for more than 1 minute), followed by a continuous infusion at 0.7 µg/kg/h, with a maximum infusion rate of 10 µg/kg/h. T

Sponsors

The first hospital of jilin university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–80 years; 2. 2019 SCAI cardiogenic shock stage C, D or E (judged by two researchers, with the disagreement resolved by PI); 3. Mechanical ventilation has been initiated, and randomization can be completed within = 5 points (based on the complete score within <= 2 hours before randomization); 5. Screening and randomization were completed within <= 6 hours from the first definite SCAI C/D/E diagnosis or the first administration of vasoactive drugs (whichever occurred earlier); 6. Obtained consent from the patient or legal representative; Delayed consent can be enabled in emergency situations, with supplementary signing within 48 hours.

Exclusion criteria

Exclusion criteria: 1. History of allergy to remifentanil, fentanyl or related drugs; 2. Mental disorders (such as inability to cooperate with the study), chronic pain, epilepsy, severe brain diseases leading to increased ICP; 3. Severe coma (GCS <= 5 points and no need for sedation/analgesia support); 4. Severe liver or kidney dysfunction (such as eGFR < 30 ml/min/1.73m², Child-Pugh C grade); 5. Patients with terminal malignant tumors, pregnant or lactating women, or those who cannot undergo long-term follow-up due to terminal conditions; 6. Participated in other drug clinical trials in the past 1 month.

Design outcomes

Primary

MeasureTime frame
24-hour lactate clearance rate;

Secondary

MeasureTime frame
72-hour hemodynamic stability composite endpoint;Core hemodynamic parameters;Cardiac function indicators;Cardiac troponin ;6-hour lactate clearance rate;Duration of mechanical ventilation;Length of stay in CCU;Adverse event occurred;

Countries

China

Contacts

Public ContactYushi Wang

The First Hospital of Jilin University

yushi@jlu.edu.cn+86 431 8878 2417

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026