Refractory dyspnoea in patients hospitalised for acute decompensation of heart failure
Conditions
Interventions
Trade Name: FENTANEST 0,05 mg/ml SOLUCION INYECTABLE , 5 ampollas de 3 ml
Pharmaceutical Form: Injection
INN or Proposed INN: FENTANYL
Other descriptive name: FENTANYL
Concentration unit: mg/ml millig
Sponsors
Fundació Assistencial Mútua Terrassa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years or more. 2. Hospitalized at the Hospital Universitari Mútua Terrassa in the internal medicine unit and complex chronic patient unit, due to decompensation of the heart failure, of any etiology. Patients may be included only once in each hospital admission; in case of re-admission for the same reason they may be included again. 3. In optimized treatment of their heart failure decompensation at the discretion of the responsible physician . 4. Persists with refractory dyspnea despite treatment. 5. Patient has received two or more doses of 3mg of subcutaneous morphine on demand for dyspnea in the previous 24 hours, by indication of the responsible physician. 6. The patient gives informed consent attesting to his correct understanding of the purposes and procedures of the study and his willingness to voluntarily participate in the study. In the event that the patient, due to his/her personal conditions or clinical situation, is unable to give consent, the family member or primary caregiver of reference will receive the explanations and give consent. 7. It is expected that the patient will be able to complete the questionnaires on the efficacy and tolerability of the drugs administered. Otherwise, it is expected that the family member or primary caregiver of reference may complete these questionnaires. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1. History of alcohol or drug abuse 2. Allergy to fentanyl or morphine 3. Contraindication for the use of opioids: 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 states of shock. In case of infection at the injection site and in patients with severe coagulation disorders, administration by epidural or intrathecal route is contraindicated. 4. Concomitant treatment with opioids for other causes. 5. Simultaneous participation in another study or clinical trial. 6. Grade C liver disease (Child-Pugh score > 12.5) 7. Concomitant use of drugs that can alter fentanyl concentrations such as cytochrome P450 3A4 inhibitors and inducers (CYP3A4). Inhibitors: amiodarone, cimetidine, clarithromycin, diltiazem, erythromycin, fluconazole, itraconazole, ketoconazole, nefazodone, ritonavir, verapamil and voriconazole. Inducers: carbamazepine, phenobarbital, phenytoin and rifampicin. 8. The risk of mortality in the next 48 hours is considered high. 9. The patient refuses informed consent. 10. The patient is unable to give consent and the family member or primary caregiver referral is unable to give consent or refuses consent. 11. Patients in whom the physician responsible for the patient during his/her hospitalization considers that they should not enter the study, either because they believe that the administration of opioids in continuous perfusion is indicated or contraindicated, or for any other reason. These patients will not be randomized, although they will be asked for informed consent to collect their data, including the various scales that will be passed on to the rest of the patients included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effectiveness and tolerability of fentanyl in continuous parenteral infusion, compared to morphine administration in bolus on demand, for the treatment of refractory dyspnoea in patients hospitalized for acute decompensation of heart failure.;Secondary Objective: Not applicable;Primary end point(s): Decrease in the average daily intensity of dyspnea, is the main criterion of effectiveness. The intensity of the dyspnea is evaluated by the patient himself by means of a Numerical Analogical Scale (ENA) and a Visual Analogical Scale (VAS) of dyspnea. The effectiveness of the treatment is evaluated by comparing the ANE and VAS of dyspnea in the first evaluation or 0h with the ANE and VAS of dyspnea in the following consecutive evaluations or 24h, 48h and 72h. We consider clinically significant improvement the decrease of 2 points or more in the ANE, or 20mm or more in the VAS, or 30% or more in the ANE and VAS score.;Timepoint(s) of evaluation of this end point: 24 hours, 48 hours and 72h. After treatment discontinuation a follow-up will be performed every 24 hours for 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A- Improvement of punctuation in the dyspnea-12 scale B- Improvement of the patient's general condition. The patient evaluates his/her general condition using the Edmonton Symptom Assessment System (ESAS) and the Patient Global Improvement Impression Scale (PGIC-I for the patient); see the end of this section. The reference clinician also evaluates the change in the patient's overall condition using the Clinician's Global Improvement Impression Scale (CGIC-I for the clinician); see the end of this section. We consider clinically significant changes of 2 points or more, or 30% or more, in each of the AES that make up the ESAS, or 30% or more of the average total score of the ESAS, or 1 point or more in the ICG (59). We expect to find significant correlation between changes in the ENA and changes in the GIC. We also expect to find significant correlation between the PGIC and the CGIC. C- Decrease in the number of doses of rescue medication (3mg morphine sc) D- Absence of neurological toxicity by opioids. Opioid neurological toxicity is understood to be the appearance of nausea and/or drowsiness, and is determined by the patient him/herself by means of ANA and EVA of both symptoms. Neurological toxicity is evaluated by comparing the EVA and EVA of nausea and somnolence in the first evaluation with the ENA and EVA of the following consecutive evaluations or 24h, 48h and 72h. Increase of 2 points or more in the ANE, or 20mm or more in the EVA, or 30% or more in the ANE or EVA score will be interpreted as development of opioid neurological toxicity. E- Absence of intestinal toxicity. The presence of intestinal toxicity is determined by the physician of the research team through abdominal auscultation, evaluating the intestinal sounds as normal, increased, decreased or absent; to conclude absence of intestinal sounds, auscultation should last three minutes. F- Absence of other adverse events G- That the interruption of treatment due to lack of | — |
Countries
Spain
Contacts
Public ContactAdministrative clinical trial desk
Fundació de recerca Mútua Terrassa
Outcome results
None listed