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Acute Respiratory FailurePhase 2OPIDYSNCT04358133

Low Dose Morphine to Relieve Dyspnea in Acute Respiratory Failure (OPIDYS)

A Phase 2 study testing Chlorhydrate de morphine and NaCl 0,9%, in people with Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates a pharmacological intervention to relieve dyspnea in intensive care unit patients. Indeed, opioids can be particularly beneficial since 1) dyspnea and pain share many similarities, 2) the benefit of opioids on dyspnea has been clearly demonstrated in other populations. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Respiratory Failure
What is being tested?
Chlorhydrate de morphine and NaCl 0,9%,
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteFrance
Study dates
16 Dec 2020to 7 Oct 2022
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Adult patients ≤ 75 years
  • Admitted in intensive care for an acute respiratory failure defined as a respiratory rate> 24 / min or signs of respiratory distress such as labored breathing or paradoxical inspiration, or SpO2 <90% in ambient air
  • Spontaneous ventilation, either under standard oxygen, high flow oxygen or non invasive ventilation
  • Dyspnea ≥ 40 on an dyspnea-VAS from zero (no dyspnea) to 100 (worst possible dyspnea)
  • Richmond agitation and sedation scale (RASS) between 0 and 2.
  • No confusion, as defined by the CAM-ICU
  • Signed informed consent

Who cannot join

  • Intubated patient
  • Intubation planned upon admission
  • Hearing or visual impairment
  • Insufficient command of French
  • Previous psychiatric or cognitive disorders known
  • Moribund patient
Show all 16Show fewer
  • Known hypersensitivity to opioids
  • Severe renal insufficiency (creatinine clearance <30 ml / min)
  • Severe hepatocellular insufficiency (factor V <50%)
  • Any formal contra-indication of opiates
  • Opioid use within the 24 hours before inclusion
  • Pregnancy or breastfeeding
  • Minor and protected adult
  • Exclusion period due to inclusion in another clinical trial
  • Previous inclusion in this study
  • No affiliation to social security

Trial locations and contacts

1 site in 1 country.

France1 site

  • Groupe Hospitalier Pitié Salpetriere

    Paris, 75013

Other trials in France

About this study

Official title: Relieving Dyspnea With Low Dose of Morphine in Patients Admitted to the Intensive Care Unit for an Acute Respiratory Failure: a Double-blind Randomized Controlled Pilot Study

This study evaluates a pharmacological intervention to relieve dyspnea in intensive care unit patients. Indeed, opioids can be particularly beneficial since 1) dyspnea and pain share many similarities, 2) the benefit of opioids on dyspnea has been clearly demonstrated in other populations. However, to date, data regarding the impact of morphine on dyspnea in intensive care unit patients admitted for acute respiratory failure are scarce. There may be a reluctance of physicians to prescribe opioids that is not scientifically justified.

The study will focus on patient reported outcome (PRO) criteria. The ultimate goal of this pilot study is to design the protocol of a future pragmatic trial.

Read the detailed description

Randomized, double-blind, placebo-controlled, parallel-group, single-center phase 2 pilot study.The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol. The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm Patients will be randomized 1:1 between low-dose titrated morphine (experimental group) and placebo (control group). The other treatments will be similar in both groups, according to the protocol and the recommendations.

Severe dyspnea will be assessed for regularly Patients will be followed for 48 hours: 24-hour treatment duration, evaluation of primary endpoint for first 24 hours, collection of adverse events for 48 hours.

Being tested
Chlorhydrate de morphine, NaCl 0,9%,
Keywords
Acute respiratory failure, Dyspnea, Opioids, Comfort, Intensive care unit
Medical subject headings
Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chlorhydrate de morphineDrug

    The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol

  • NaCl 0,9%,Drug

    The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm

Study groups in NCT04358133
Study groupRoleWhat they receive
Chlorhydrate de morphineExperimentalinitial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea <40 then relay subcut
Receives: Drug: Chlorhydrate de morphine
NaCl 0,9%Placebo comparatorinitial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea <40 then relay subcut
Receives: Drug: NaCl 0,9%,

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average dyspnea over 24 hours

    Dyspnea will be assessed by VAS-dyspnea (ranging from zero, no dyspnea to 100, worst possible dyspnea) patient reported outcome criteria (PRO).

    Measured: systematically evaluated every 4 hours over 24 hours and whenever necessary

Secondary outcomes (28)

  1. Intensity of dyspnea

    patient reported outcome measure (PRO) ; min=0;max=100(worse)

    Measured: every 4 hours over 24 hours

  2. Incidence of severe dyspnea (dyspnea ≥40)

    patient reported outcome measure (PRO) ; min=0;max=100(worse)

    Measured: within 24 hours

  3. Anxiety

    Patient reported outcome measure (PRO) ; min=0;max=100(worse)

    Measured: every 4 hours as well as over the first 24 hours

  4. Incidence of moderate to severe anxiety

    Incidence of moderate to severe anxiety (PRO) ; min=0;max=100(worse)

    Measured: every 4 hours over 24 hours

  5. Intubation rate

    Intubation rate

    Measured: within the first 48 hours

  6. Vigilance level (Glasgow Coma Scale : impaired alertness defined by Glasgow Coma Scale ≤ 12)

    Vigilance level ; GCS : min=3(worse) ;max=15

    Measured: every 4 hours as well as the first 48 hours

  7. Incidence of coma

    Incidence of coma

    Measured: within the first 48 hours

  8. Incidence of delirium

    Incidence of delirium

    Measured: within the first every 4 hours as well as over the first 48 hours

  9. Respiratory rate

    Respiratory rate

    Measured: every 4 hours as well as over the first 24 hours

  10. Proportion of patients requiring the transition from one oxygenation technique to another

    Proportion of patients requiring the transition from one oxygenation technique to another

    Measured: At the end of the study (12 months)

  11. Intensity of pain

    Patient reported outcome measure (PRO) ; min=0;max=100(worse)

    Measured: every 4 hours

  12. Duration of night sleep the first night

    Duration of night sleep the first night (number of hours)

    Measured: at the end of the first night

  13. Quality of sleep the first night

    Patient reported outcome measure (PRO); min=0;max=100(worse)

    Measured: at the end of the first night

  14. Severity of dry eye

    Patient reported outcome criteria (PRO); min=0;max=100(worse)

    Measured: in the first 24 hours

  15. Severity of dry nose

    Patient reported outcome criteria (PRO); min=0;max=100(worse)

    Measured: in the first 24 hours

  16. Severity of feeling of gastric distension

    Patient reported outcome criteria (PRO); min=0;max=100(worse)

    Measured: in the first 24 hours

  17. Constipation

    Constipation (PRO); min=0;max=100(worse)

    Measured: in the first 48 hours

  18. Nausea

    Patient reported outcome criteria (PRO) ;min=0;max=100(worse)

    Measured: in the first 48 hours

  19. Nurses' adherence to the protocol

    Nurses' adherence to the protocol (questionnaire)

    Measured: in the first 24 hours

  20. Nurses' satisfaction with the protocol

    Nurses' satisfaction with the protocol (questionnaire)

    Measured: in the first 24 hours

  21. Number of non invasive ventilation sessions

    Number of non invasive ventilation sessions

    Measured: in the first 24 hours

  22. Total duration of non invasive ventilation

    Total duration of non invasive ventilation (number of hours)

    Measured: in the first 24 hours

  23. Tolerance of non invasive ventilation

    Tolerance of non invasive ventilation (PRO) ;min=0;max=100(worse)

    Measured: in the first 24 hours

  24. Duration of HFNCO (high-flow nasal canula oxygenation)

    Duration of HFNCO (number of hours)

    Measured: in the first 24 hours

  25. Tolerance of HFNCO(high-flow nasal canula oxygenation)

    Tolerance of HFNCO : number of adverses events

    Measured: in the first 24 hours

  26. Duration of standard oxygen

    Duration of standard oxygen (number of hours)

    Measured: in the first 24 hours

  27. Tolerance of standard oxygen

    Tolerance of standard oxygen : number of adverses events

    Measured: in the first 24 hours

  28. Any adverse or serious event occurring

    Any adverse or serious event occurring

    Measured: within the first 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start16 Dec 2020
  3. Primary completion7 Oct 2022
  4. Study completion7 Oct 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled, parallel-group,single center, phase 2 pilot study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04358133
Sponsor's protocol ID
CRC18023
Other IDs
2019-003091-39, 2019
Acronym
OPIDYS
Status last verified
Oct 2022
First submitted
31 Mar 2020
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Publications

  • Deleris R, Bureau C, Lebbah S, Decavele M, Dres M, Mayaux J, Similowski T, Dechartres A, Demoule A. Low dose of morphine to relieve dyspnea in acute respiratory failure: the OpiDys double-blind randomized controlled trial. Respir Res. 2024 Jul 16;25(1):280. doi: 10.1186/s12931-024-02867-2.

    PubMed 39014448

  • Demoule A, Deleris R, Bureau C, Lebbah S, Decavele M, Dres M, Similowski T, Dechartres A. Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study. Trials. 2022 Sep 30;23(1):828. doi: 10.1186/s13063-022-06754-3.

    PubMed 36175968

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chlorhydrate de morphine and NaCl 0,9%, in people with Acute Respiratory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. 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: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average dyspnea over 24 hours (time frame: systematically evaluated every 4 hours over 24 hours and whenever necessary). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04358133, which also lists 2 linked publications.

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 25 Oct 2022.

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