RecruitingPhase 2NCT07224620

Fentanyl Versus Hydromorphone in Patients on Mechanical Ventilation

Fentanyl Versus Hydromorphone as First Line Strategy in Patients on Mechanical Ventilation, a Pilot Pragmatic Randomized Superiority Clinical Trial: the FenHydro Trial


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

300 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with respiratory failure who require mechanical ventilation are not only at risk of death, but also of complications of prolonged ICU stay. Patients may have significant functional decline, impact in quality of life, develop psychiatric disorders and at long-term can lead to significant cost to society. Although sedation and analgesia are considered only supportive therapy, several studies have shown that in patients on mechanical ventilation, different approaches can have significant impact on patient centered outcomes. However, to date, randomized clinical trials on critically ill patients have mostly evaluated the sedative agent but not the analgesic agent. Although morphine and its derivates are the most common used opioid analgesic agents in the critical care setting, only some retrospective studies and some prospective studies compared them head-to-head (ramifentanyl versus morphine and fentanyl versus morphine). Current guidelines recommend choosing the analgesic agent based on pharmacokinectics, physician experience and side-effects profile. To evaluate the differences of two standard-of-care analgosedation agents, the FenHydro trial will be a cluster randomized, pragmatic, pilot and feasibility superiority clinical trial in mechanically ventilated patients in the ICU. The main question the study hopes to answer is whether there is any difference in morphine milligram equivalents administered during mechanical ventilation.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Admitted to either MICU A, B, C or FICU at Beth Israel Deaconess Medical Center
  • Requiring mechanical ventilation
  • Felt by primary team to require opioid infusion for analgosedation

Exclusion Criteria4

  • Age \< 18 years old
  • Do not intubate orders prior to enrollment
  • Comfort measures only
  • Contraindication to fentanyl or hydromorphone

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Interventions

DRUGfentanyl

Suggested initial continuous infusion * Route: Intravenous * Dose: 0-200 mcg/hr (max 1,440 MME/day) * Initial dose: 50mcg/hr * Concentration: 50 mcg/mL * Bolus: 50-200mcg up to every 5 minutes as needed * Continuous infusion adjustment: Increase in the continuous infusion if sedation not at goal after 3 bolus doses, increase by 25 mcg/hr every 60 minutes Titration of dose, initial dose, adjustments and bolus are just suggested. The primary team is allowed to modify them based on clinical judgement.

DRUGHydromorphone

Suggested initial continuous infusion * Route: Intravenous * Dose: 0-3 mg/hr (max 1,440 MME/day) * Initial dose: 0.5mg/hr * Concentration: 0.2 mg/mL * Bolus: 0.5-2mg up to every 5 minutes as needed * Continuous infusion adjustment: Increase in the continuous infusion if sedation not at goal after 3 bolus doses, increase by 0.25 mg/hr every 60 minutes Titration of dose, initial dose, adjustments and bolus are just suggested. The primary team is allowed to modify them based on clinical judgement.


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT07224620


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