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A randomised, double-blind, comparative clinical trial of the effectiveness and tolerability of fentanyl in continuous parenteral perfusion versus on-demand bolus of morphine for the treatment of refractory dyspnoea in patients hospitalised for acute dec
EU CTIS ID: 2024-520025-36-00
What this study is testing
To evaluate the effectiveness and tolerability of fentanyl in PCSC, compared with the administration of morphine in BSC on demand, for the treatment of refractory dyspnea in patients hospitalized for acute decompensation of HF.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age equal to or greater than 18 years. 2. Hospitalized at the Mútua Terrassa University Hospital in the internal medicine units and complex chronic patient unit, due to HF decompensation, of any etiology. Patients may be included only once during each hospital admission; In case of re-entry for the same reason, they may be included again. 3. In optimized treatment of their HF decompensation at the discretion of the specialist doctor responsible for the case. 4. Refractory dyspnea persists despite treatment. 5. Has received two or more doses of 3 mg of SC morphine on demand for dyspnea in the previous 24 hours, as indicated by the responsible physician. 6. The patient gives informed consent that attests to his or her correct understanding of the purposes and procedures of the study and his desire to voluntarily participate in the study. In the event that the patient, due to his or her personal conditions or clinical situation, cannot grant consent, it will be the family member or primary caregiver who receives the explanations and grants consent. 7. It is expected that the patient will be able to complete questionnaires on the effectiveness and tolerability of the drugs administered. Otherwise, it is expected that the family member or the main reference caregiver will be able to complete these questionnaires.
You likely can't join if
- 1. History of alcohol or drug abuse. 2. Allergy to fentanyl or morphine 3. Contraindication to opioid use: Known hypersensitivity to morphine. Patients with respiratory depression or severe obstructive respiratory disease. Patients with acute bronchial asthma. Patients treated with monoamine oxidase inhibitors or during the 14 days following the suspension of such treatment. Patients with acute and/or severe liver disease. Patients with head injury; increased intracranial pressure. Patients in coma. Patients with spasms of the renal and biliary tract. Patients with acute alcoholism. Patients at risk of paralytic ileus. Patients with ulcerative colitis. Patients in shock. In case of infection at the injection site and in patients with severe coagulation disorders, epidural or intrathecal administration is contraindicated. 4. Concomitant treatment with opioids for other causes. 5. Simultaneous participation in another study or clinical trial.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.