Weaning FailureNCT03894189
The Effect of Doxapram Versus Theophylline on Diaphragmatic Function
A study testing Doxapram Hydrochloride and Theophylline in people with Weaning Failure, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Doxapram is licensed for drug-induced post-anesthesia respiratory depression , arousal effect and return airway protective reflexes caused by barbiturates, volatile anesthetics, nitrous oxide or benzodiazepines over dosage. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Weaning Failure
- What is being tested?
- Doxapram Hydrochloride and Theophylline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- May 2019to Dec 2019
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Age older than 60 years
- Preoperative left ventricular ejection fraction less than 30%
- Chronic obstructive pulmonary disease
- Significant hepatic disease (alanine aminotransferase or aspartate aminotransferase >150 U/l).
- Renal failure (creatinine >200 μm).
- History of seizure, or stroke.
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- History of diaphragmatic palsy, cervical spine injury, or neuromuscular disease (eg, myasthenia gravis, Guillain-Barré syndrome).
- Lesion adjacent to the diaphragm
- Intra-abdominal hypertension (intra-abdominal pressure ≥12 mm Hg )
- Known allergy to the study drugs.
- The Post enrollment exclusion criteria:
- Postoperative hemorrhage (chest tube drainage ≥ 200 ml/h).
- Surgical complications necessitating reoperation.
- Postoperative cardiac failure necessitating high-dose inotropes or intra -aortic balloon pump.
- Refractory hypoxemia (ratio of arterial oxygen tension [PaO2] to fraction of inspired oxygen [FIO2] <150 mmHg).
- Occurrence of neurologic deficit.
- -Myocardial ischemia (ST-segment depression) lasting more than 30 min
- Failure of spontaneous breathing trial.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University Hospital
Banī Suwayf
Samaa Rashwan, MD, 0201270159125
About this study
Official title: The Effect of Doxapram Versus Theophylline on Diaphragmatic Function and Weaning From Mechanical Ventilation After Open Heart Surgery
Doxapram is licensed for drug-induced post-anesthesia respiratory depression , arousal effect and return airway protective reflexes caused by barbiturates, volatile anesthetics, nitrous oxide or benzodiazepines over dosage.
Value of theophylline to stimulate the respiratory neuronal network has been examined by previous studies and increases the activity of respiratory muscles, including the intercostal , transversus abdominis muscles and the diaphragm, it also has bronchodilator and anti-inflammatory effects.
Read the detailed description
This randomized comparative study will be conducted in the post-surgical cardio-thoracic intensive care unit in Beni -Suef University Hospital after approval of the department of anesthesiology, surgical ICU and pain management , and cardio thoracic department and the local ethics and research committee, and obtaining written informed consents from the patients to compare the effect of doxapram versus theophylline on diaphragmatic function using ultrasonography parameter: thickening fraction of the diaphragmatic muscle during respiration which defined as [(thickness at end-inspiration - thickness at end-expiration)/thickness at end-expiration] during spontaneous breathing trial as a primary outcome and its effect on weaning time and weaning success rate as secondary outcomes.
- Conditions
- Weaning Failure
- Being tested
- Doxapram Hydrochloride, Theophylline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxapram HydrochlorideDrug
Also called Doxapram
the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug
TheophyllineDrug
the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug
| Study group | Role | What they receive |
|---|---|---|
| doxapram group (GROUP D) | Active comparator | The patients in this group will receive loading dose of (1 mg/kg) followed by an infusion of (1mg/kg/h) Receives: Drug: Doxapram Hydrochloride; Drug: Theophylline |
| theophylline group (GROUP T) | Active comparator | the therapeutic loading dose (5mg/kg) followed by an infusion of (0.5 mg/kg/h) Receives: Drug: Doxapram Hydrochloride; Drug: Theophylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of doxapram versus theophylline on diaphragmatic function
: thickening fraction of the diaphragmatic muscle during respiration which defined as [(thickness at end-inspiration - thickness at end-expiration)/thickness at end-expiration](18) (19) during spontaneous breathing trial as a primary outcome and its effect on weaning time and weaning success rate as secondary outcomes.
Measured: the study drugs will be infused for 1 hour,At the end of 60 min of SBT, the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa Rashwan, Beni-Suef University
- Investigators
- Samaa ak Rashwan, MD, Principal investigator, Assisstant proffesor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894189
- Sponsor's protocol ID
- Faculty Of Medicine,Beni -Suef
- Status last verified
- Mar 2019
- First submitted
- 23 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Doxapram Versus Theophylline on Diaphragmatic Function and Weaning From Mechanical Ventilation After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT03894189
- Acronym / sponsor ID
- Faculty Of Medicine,Beni -Suef
- Conditions
- Weaning Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Doxapram is licensed for drug-induced post-anesthesia respiratory depression , arousal effect and return airway protective reflexes caused by barbiturates, volatile anesthetics, nitrous oxide or benzodiazepines over dosage.
Value of theophylline to stimulate the respiratory neuronal network has been examined by previous studies and increases the activity of respiratory muscles, including the intercostal , transversus abdominis muscles and the diaphragm, it also has bronchodilator and anti-inflammatory effects.
Detailed description
This randomized comparative study will be conducted in the post-surgical cardio-thoracic intensive care unit in Beni -Suef University Hospital after approval of the department of anesthesiology, surgical ICU and pain management , and cardio thoracic department and the local ethics and research committee, and obtaining written informed consents from the patients to compare the effect of doxapram versus theophylline on diaphragmatic function using ultrasonography parameter: thickening fraction of the diaphragmatic muscle during respiration which defined as [(thickness at end-inspiration - thickness at end-expiration)/thickness at end-expiration] during spontaneous breathing trial as a primary outcome and its effect on weaning time and weaning success rate as secondary outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxapram group (GROUP D) | Active comparator | Drug: Doxapram Hydrochloride, Drug: TheophyllineThe patients in this group will receive loading dose of (1 mg/kg) followed by an infusion of (1mg/kg/h) |
| theophylline group (GROUP T) | Active comparator | Drug: Doxapram Hydrochloride, Drug: Theophyllinethe therapeutic loading dose (5mg/kg) followed by an infusion of (0.5 mg/kg/h) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Age older than 60 years
- Preoperative left ventricular ejection fraction less than 30%
- Chronic obstructive pulmonary disease
- Significant hepatic disease (alanine aminotransferase or aspartate aminotransferase >150 U/l).
- Renal failure (creatinine >200 μm).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxapram HydrochlorideAlso: Doxapramthe diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug | Drug | doxapram group (GROUP D), theophylline group (GROUP T) |
| Theophyllinethe diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug | Drug | doxapram group (GROUP D), theophylline group (GROUP T) |
Primary outcome
the effect of doxapram versus theophylline on diaphragmatic function
Time frame: the study drugs will be infused for 1 hour,At the end of 60 min of SBT, the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound.
: thickening fraction of the diaphragmatic muscle during respiration which defined as [(thickness at end-inspiration - thickness at end-expiration)/thickness at end-expiration](18) (19) during spontaneous breathing trial as a primary outcome and its effect on weaning time and weaning success rate as secondary outcomes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samaa ak Rashwan, MD principal investigator
Assisstant proffesor of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxapram Hydrochloride and Theophylline in people with Weaning Failure, run by Beni-Suef University at 1 site in Egypt.
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 0 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 28 Mar 2019. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samaa ak Rashwan, MD (020120159125, samakassemrashwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of doxapram versus theophylline on diaphragmatic function (time frame: the study drugs will be infused for 1 hour,At the end of 60 min of SBT, the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2019.